Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03521934
Other study ID # EFC15156
Secondary ID 2017-003510-16U1
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 15, 2018
Est. completion date June 5, 2020

Study information

Verified date September 2022
Source Lexicon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: - The total occurrences of HHF and urgent visit for HF - The occurrence of CV death - The occurrence of all-cause mortality - The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke - Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score - Change in estimated glomerular filtration rate (eGFR)


Description:

The estimated study duration for a given participants will be approximately 3 to 24 months.


Recruitment information / eligibility

Status Terminated
Enrollment 1222
Est. completion date June 5, 2020
Est. primary completion date June 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion criteria: - Type 2 Diabetes Mellitus. - Admitted to the hospital, or urgent heart failure visit for worsening heart failure. - Prior diagnosis of heart failure (> 3 months). - Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for > 30 days. - Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge. - Brain natriuretic peptide (BNP) =150 picograms per milliliter (pg/mL) (=450 pg/mL for participants with atrial fibrillation) or N-terminal B-type natriuretic peptide =600 pg/mL (=1800 pg/mL for participants with atrial fibrillation). - Participants with Left Ventricular Ejection Fraction <40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated. - Signed written informed consent. Exclusion criteria: - Age < 18 years or > 85 years. - Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack. - Cardiac surgery or coronary procedure within 1 month or planned during study. - Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization. - Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study. - Acute coronary syndromes within 3 months prior to Randomization. - Hemodynamically significant uncorrected primary valvular disease. - Significant pulmonary disease contributing substantially to the participant's dyspnea. - End stage Heart Failure. - History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening. - History of stroke within 3 months prior to randomization. - History of dialysis within 1 year prior to randomization. - History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant). - Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 milliliter per minute per 1.72 meter square (mL/min/1.73 m^2). - Pregnancy. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design


Intervention

Drug:
Sotagliflozin
Pharmaceutical form: tablet Route of administration: oral
Placebo
Pharmaceutical form: tablet Route of administration: oral

Locations

Country Name City State
Argentina Investigational Site Number 0320009 Caba
Argentina Investigational Site Number 0320031 Caba
Argentina Investigational Site Number 0320016 Capital Federal
Argentina Investigational Site Number 0320002 Ciudad De Buenos Aires
Argentina Investigational Site Number 0320010 Cordoba
Argentina Investigational Site Number 0320011 Cordoba
Argentina Investigational Site Number 0320003 Córdoba
Argentina Investigational Site Number 0320024 Córdoba
Argentina Investigational Site Number 0320025 Córdoba
Argentina Investigational Site Number 0320001 Corrientes
Argentina Investigational Site Number 0320022 Corrientes
Argentina Investigational Site Number 0320007 La Plata
Argentina Investigational Site Number 0320029 La Plata
Argentina Investigational Site Number 0320006 Merlo
Argentina Investigational Site Number 0320005 Moron
Argentina Investigational Site Number 0320012 Olivos
Argentina Investigational Site Number 0320023 Quilmes
Argentina Investigational Site Number 0320013 Rosario
Argentina Investigational Site Number 0320018 Rosario
Argentina Investigational Site Number 0320008 Salta
Argentina Investigational Site Number 0320020 San Martin
Argentina Investigational Site Number 0320019 San Miguel De Tucuman
Argentina Investigational Site Number 0320028 San Miguel De Tucuman
Argentina Investigational Site Number 0320015 Santa Fe
Argentina Investigational Site Number 0320017 Santa Fe
Argentina Investigational Site Number 0320030 Tucuman
Argentina Investigational Site Number 0320004 Villa Belgrano
Argentina Investigational Site Number 0320014 Villa Maria
Australia Investigational Site Number 0360007 Murdoch
Australia Investigational Site Number 0360001 Wollongong
Austria Investigational Site Number 0400006 Braunau
Austria Investigational Site Number 0400002 Feldkirch
Austria Investigational Site Number 0400007 Graz
Austria Investigational Site Number 0400005 Linz
Austria Investigational Site Number 0400004 Salzburg
Austria Investigational Site Number 0400001 Wien
Austria Investigational Site Number 0400003 Wien
Belgium Investigational Site Number 0560002 Aalst
Belgium Investigational Site Number 0560007 Gent
Belgium Investigational Site Number 0560004 Kortrijk
Belgium Investigational Site Number 0560001 Leuven
Belgium Investigational Site Number 0560003 Liège
Belgium Investigational Site Number 0560005 Mol
Belgium Investigational Site Number 0560006 Mons
Belgium Investigational Site Number 0560008 Roeselare
Brazil Investigational Site Number 0760009 Belo Horizonte
Brazil Investigational Site Number 0760024 Belo Horizonte
Brazil Investigational Site Number 0760002 Blumenau
Brazil Investigational Site Number 0760011 Brasilia
Brazil Investigational Site Number 0760005 Campinas
Brazil Investigational Site Number 0760006 Campinas
Brazil Investigational Site Number 0760023 Fortaleza
Brazil Investigational Site Number 0760018 Goiania
Brazil Investigational Site Number 0760010 Passo Fundo
Brazil Investigational Site Number 0760003 Porto Alegre
Brazil Investigational Site Number 0760007 Porto Alegre
Brazil Investigational Site Number 0760013 Porto Alegre
Brazil Investigational Site Number 0760020 Porto Alegre
Brazil Investigational Site Number 0760021 Porto Alegre
Brazil Investigational Site Number 0760004 Recife
Brazil Investigational Site Number 0760001 Sao Jose Do Rio Preto
Brazil Investigational Site Number 0760008 Sao Paulo
Brazil Investigational Site Number 0760012 Sao Paulo
Brazil Investigational Site Number 0760017 Votuporanga
Canada Investigational Site Number 1240013 Cambridge
Canada Investigational Site Number 1240006 Granby
Canada Investigational Site Number 1240015 Halifax
Canada Investigational Site Number 1240002 Montreal
Canada Investigational Site Number 1240018 Montreal
Canada Investigational Site Number 1240019 Montreal
Canada Investigational Site Number 1240004 Peterborough
Canada Investigational Site Number 1240014 Quebec
Canada Investigational Site Number 1240007 Scarborough
Canada Investigational Site Number 1240005 Sherbrooke
Canada Investigational Site Number 1240001 Toronto
Canada Investigational Site Number 1240011 Toronto
Canada Investigational Site Number 1240009 Trois-Rivières
Chile Investigational Site Number 1520009 Concepción
Chile Investigational Site Number 1520003 Santiago
Chile Investigational Site Number 1520004 Santiago
Chile Investigational Site Number 1520005 Santiago
Chile Investigational Site Number 1520006 Santiago
Chile Investigational Site Number 1520011 Santiago
Chile Investigational Site Number 1520012 Santiago
Chile Investigational Site Number 1520013 Santiago
Chile Investigational Site Number 1520002 Temuco
Chile Investigational Site Number 1520010 Vina Del Mar
Chile Investigational Site Number 1520001 Viña Del Mar
Czechia Investigational Site Number 2030001 Brno
Czechia Investigational Site Number 2030003 Brno
Czechia Investigational Site Number 2030004 Brno
Czechia Investigational Site Number 2030014 Kolin 3
Czechia Investigational Site Number 2030010 Kromeriz
Czechia Investigational Site Number 2030005 Liberec
Czechia Investigational Site Number 2030013 Mestec Kralove
Czechia Investigational Site Number 2030018 Praha 10
Czechia Investigational Site Number 2030002 Praha 2
Czechia Investigational Site Number 2030017 Praha 5
Czechia Investigational Site Number 2030007 Praha 5 - Motol
Czechia Investigational Site Number 2030011 Prerov
Czechia Investigational Site Number 2030015 Pribram I
Czechia Investigational Site Number 2030006 Slany
Denmark Investigational Site Number 2080003 Aarhus N
Denmark Investigational Site Number 2080004 Ålborg
Denmark Investigational Site Number 2080002 Glostrup
Denmark Investigational Site Number 2080001 Herlev
Denmark Investigational Site Number 2080005 København Nv
Finland Investigational Site Number 2460004 Espoo
Finland Investigational Site Number 2460001 Helsinki
Finland Investigational Site Number 2460002 Jyväskylä
Finland Investigational Site Number 2460003 Oulu
Finland Investigational Site Number 2460005 Seinäjoki
France Investigational Site Number 2500009 Chambray Les Tours
France Investigational Site Number 2500008 La Tronche
France Investigational Site Number 2500004 Le Chesnay
France Investigational Site Number 2500002 Le Coudray
France Investigational Site Number 2500001 Lille
France Investigational Site Number 2500007 Nantes Cedex 1
France Investigational Site Number 2500012 Nice Cedex 1
France Investigational Site Number 2500006 Paris
France Investigational Site Number 2500003 Paris Cedex 18
France Investigational Site Number 2500005 Toulouse Cedex 9
France Investigational Site Number 2500013 Vandoeuvre-Les-Nancy Cedex
Germany Investigational Site Number 2760020 Bad Nauheim
Germany Investigational Site Number 2760016 Bad Oeynhausen
Germany Investigational Site Number 2760001 Berlin
Germany Investigational Site Number 2760002 Berlin
Germany Investigational Site Number 2760013 Berlin
Germany Investigational Site Number 2760019 Berlin
Germany Investigational Site Number 2760025 Bielefeld
Germany Investigational Site Number 2760005 Bonn
Germany Investigational Site Number 2760021 Bremen
Germany Investigational Site Number 2760035 Coburg
Germany Investigational Site Number 2760006 Dortmund
Germany Investigational Site Number 2760032 Dortmund
Germany Investigational Site Number 2760029 Erfurt
Germany Investigational Site Number 2760018 Essen
Germany Investigational Site Number 2760033 Frankfurt Am Main
Germany Investigational Site Number 2760009 Greifswald
Germany Investigational Site Number 2760022 Heidelberg
Germany Investigational Site Number 2760031 Heidelberg
Germany Investigational Site Number 2760027 Köln
Germany Investigational Site Number 2760034 Lahr
Germany Investigational Site Number 2760030 Langen
Germany Investigational Site Number 2760014 Leverkusen
Germany Investigational Site Number 2760036 Limburg
Germany Investigational Site Number 2760012 Ludwigshafen
Germany Investigational Site Number 2760028 Merseburg
Germany Investigational Site Number 2760011 Rotenburg An Der Fulda
Germany Investigational Site Number 2760015 Rüsselsheim
Germany Investigational Site Number 2760007 Witten
Germany Investigational Site Number 2760026 Würzburg
Greece Investigational Site Number 3000004 Athens
Greece Investigational Site Number 3000012 Athens
Greece Investigational Site Number 3000002 Chalkida
Greece Investigational Site Number 3000009 Elefsina
Greece Investigational Site Number 3000003 Haidari
Greece Investigational Site Number 3000005 Heraklion
Greece Investigational Site Number 3000007 Ioannina
Greece Investigational Site Number 3000006 Larissa
Greece Investigational Site Number 3000001 N. Ionia
Greece Investigational Site Number 3000008 Thessaloniki
Hungary Investigational Site Number 3480018 Berettyóújfalu
Hungary Investigational Site Number 3480001 Budapest
Hungary Investigational Site Number 3480005 Budapest
Hungary Investigational Site Number 3480010 Budapest
Hungary Investigational Site Number 3480011 Budapest
Hungary Investigational Site Number 3480012 Budapest
Hungary Investigational Site Number 3480014 Budapest
Hungary Investigational Site Number 3480015 Budapest
Hungary Investigational Site Number 3480016 Budapest
Hungary Investigational Site Number 3480019 Budapest
Hungary Investigational Site Number 3480007 Debrecen
Hungary Investigational Site Number 3480002 Dombóvár
Hungary Investigational Site Number 3480017 Gyula
Hungary Investigational Site Number 3480008 Hódmezövásárhely
Hungary Investigational Site Number 3480020 Kistarcsa
Hungary Investigational Site Number 3480009 Komárom
Hungary Investigational Site Number 3480013 Pécs
Hungary Investigational Site Number 3480003 Szekesfehervar
Hungary Investigational Site Number 3480006 Zalaegerszeg
Israel Investigational Site Number 3760013 Ashkelon
Israel Investigational Site Number 3760004 Hadera
Israel Investigational Site Number 3760005 Haifa
Israel Investigational Site Number 3760003 Jerusalem
Israel Investigational Site Number 3760006 Jerusalem
Israel Investigational Site Number 3760008 Jerusalem
Israel Investigational Site Number 3760010 Nahariya
Israel Investigational Site Number 3760002 Petah-Tikva
Israel Investigational Site Number 3760011 Rehovot
Israel Investigational Site Number 3760009 Safed
Israel Investigational Site Number 3760001 Tel Aviv
Israel Investigational Site Number 3760012 Tiberias
Italy Investigational Site Number 3800006 Arzignano (Vi)
Italy Investigational Site Number 3800011 Brescia
Italy Investigational Site Number 3800017 Brescia
Italy Investigational Site Number 3800005 Cortona
Italy Investigational Site Number 3800009 Ferrara
Italy Investigational Site Number 3800020 Gallipoli
Italy Investigational Site Number 3800003 Legnago
Italy Investigational Site Number 3800002 Milano
Italy Investigational Site Number 3800008 Milano
Italy Investigational Site Number 3800012 Milano
Italy Investigational Site Number 3800023 Milano
Italy Investigational Site Number 3800013 Monza
Italy Investigational Site Number 3800022 Napoli
Italy Investigational Site Number 3800018 Pavia
Italy Investigational Site Number 3800004 Perugia
Italy Investigational Site Number 3800016 Pozzilli
Italy Investigational Site Number 3800014 Rimini
Italy Investigational Site Number 3800010 Roma
Italy Investigational Site Number 3800021 Roma
Italy Investigational Site Number 3800019 Scorrano
Italy Investigational Site Number 3800007 Udine
Korea, Republic of Investigational Site Number 4100008 Bucheon-Si
Korea, Republic of Investigational Site Number 4100010 Busan
Korea, Republic of Investigational Site Number 4100004 Daegu
Korea, Republic of Investigational Site Number 4100001 Hwaseong-Si
Korea, Republic of Investigational Site Number 4100003 Incheon
Korea, Republic of Investigational Site Number 4100005 Seongnam-Si
Korea, Republic of Investigational Site Number 4100002 Seoul
Korea, Republic of Investigational Site Number 4100007 Seoul
Korea, Republic of Investigational Site Number 4100009 Seoul
Korea, Republic of Investigational Site Number 4100011 Seoul
Latvia Investigational Site Number 4280004 Daugavpils
Latvia Investigational Site Number 4280002 Liepaja
Latvia Investigational Site Number 4280001 Riga
Latvia Investigational Site Number 4280003 Riga
Lithuania Investigational Site Number 4400002 Kaunas
Lithuania Investigational Site Number 4400005 Kaunas
Lithuania Investigational Site Number 4400004 Klaipeda
Lithuania Investigational Site Number 4400006 Siauliai
Lithuania Investigational Site Number 4400001 Vilnius
Lithuania Investigational Site Number 4400003 Vilnius
Netherlands Investigational Site Number 5280003 Amsterdam
Netherlands Investigational Site Number 5280001 Breda
Netherlands Investigational Site Number 5280007 Delft
Netherlands Investigational Site Number 5280002 Doetinchem
Netherlands Investigational Site Number 5280004 Hertogenbosch
Netherlands Investigational Site Number 5280006 Rotterdam
Netherlands Investigational Site Number 5280008 Sneek
Netherlands Investigational Site Number 5280005 Veldhoven
New Zealand Investigational Site Number 5540007 Auckland
New Zealand Investigational Site Number 5540006 Christchurch
New Zealand Investigational Site Number 5540002 Hamilton
New Zealand Investigational Site Number 5540004 Lower Hutt
New Zealand Investigational Site Number 5540005 New Plymouth
New Zealand Investigational Site Number 5540003 Rotorua
Poland Investigational Site Number 6160007 Bialystok
Poland Investigational Site Number 6160017 Gdansk
Poland Investigational Site Number 6160002 Grodzisk Mazowiecki
Poland Investigational Site Number 6160014 Katowice
Poland Investigational Site Number 6160001 Krakow
Poland Investigational Site Number 6160003 Krakow
Poland Investigational Site Number 6160012 Krakow
Poland Investigational Site Number 6160021 Krakow
Poland Investigational Site Number 6160011 Leczna
Poland Investigational Site Number 6160016 Lubin
Poland Investigational Site Number 6160005 Miechow
Poland Investigational Site Number 6160022 Poznan
Poland Investigational Site Number 6160006 Torun
Poland Investigational Site Number 6160004 Warszawa
Poland Investigational Site Number 6160008 Warszawa
Poland Investigational Site Number 6160013 Warszawa
Poland Investigational Site Number 6160020 Warszawa
Poland Investigational Site Number 6160024 Warszawa
Poland Investigational Site Number 6160015 Zamosc
Portugal Investigational Site Number 6200012 Braga
Portugal Investigational Site Number 6200001 Coimbra
Portugal Investigational Site Number 6200011 Guilhufe - Penafiel
Portugal Investigational Site Number 6200004 Guimarães
Portugal Investigational Site Number 6200002 Lisboa
Portugal Investigational Site Number 6200006 Lisboa
Portugal Investigational Site Number 6200008 Porto
Portugal Investigational Site Number 6200007 Vila Franca De Xira
Portugal Investigational Site Number 6200003 Vila Nova Gaia
Portugal Investigational Site Number 6200005 Vila Real
Romania Investigational Site Number 6420014 Arad
Romania Investigational Site Number 6420006 Baia Mare
Romania Investigational Site Number 6420015 Braila
Romania Investigational Site Number 6420013 Bucharest
Romania Investigational Site Number 6420007 Bucuresti
Romania Investigational Site Number 6420008 Bucuresti
Romania Investigational Site Number 6420011 Bucuresti
Romania Investigational Site Number 6420019 Bucuresti
Romania Investigational Site Number 6420002 Cluj Napoca
Romania Investigational Site Number 6420003 Cluj Napoca
Romania Investigational Site Number 6420016 Craiova
Romania Investigational Site Number 6420004 Oradea
Romania Investigational Site Number 6420005 Oradea
Romania Investigational Site Number 6420018 Satu Mare
Romania Investigational Site Number 6420001 Targu Mures
Romania Investigational Site Number 6420012 Tg-Mures
Romania Investigational Site Number 6420009 Timisoara
Romania Investigational Site Number 6420010 Timisoara
Russian Federation Investigational Site Number 6430026 Ivanovo
Russian Federation Investigational Site Number 6430023 Kazan
Russian Federation Investigational Site Number 6430002 Kemerovo
Russian Federation Investigational Site Number 6430006 Kemerovo
Russian Federation Investigational Site Number 6430001 Moscow
Russian Federation Investigational Site Number 6430003 Moscow
Russian Federation Investigational Site Number 6430004 Moscow
Russian Federation Investigational Site Number 6430005 Moscow
Russian Federation Investigational Site Number 6430010 Moscow
Russian Federation Investigational Site Number 6430022 Moscow
Russian Federation Investigational Site Number 6430024 Moscow
Russian Federation Investigational Site Number 6430018 Nizhniy Novgorod
Russian Federation Investigational Site Number 6430013 Rostov-Na-Donu
Russian Federation Investigational Site Number 6430011 Saint-Petersburg
Russian Federation Investigational Site Number 6430017 Sochi
Russian Federation Investigational Site Number 6430007 St-Petersburg
Russian Federation Investigational Site Number 6430009 St-Petersburg
Russian Federation Investigational Site Number 6430012 St-Petersburg
Russian Federation Investigational Site Number 6430025 St-Petersburg
Russian Federation Investigational Site Number 6430016 Tomsk
Slovakia Investigational Site Number 7030001 Bratislava
Slovakia Investigational Site Number 7030003 Bratislava 3 - Kramare
Slovakia Investigational Site Number 7030004 Bratislava 37
Slovakia Investigational Site Number 7030010 Brezno
Slovakia Investigational Site Number 7030009 Dolny Kubin
Slovakia Investigational Site Number 7030002 Kosice
Slovakia Investigational Site Number 7030011 Nitra
Slovakia Investigational Site Number 7030008 Trnava
Spain Investigational Site Number 7240016 Alicante
Spain Investigational Site Number 7240015 Badalona
Spain Investigational Site Number 7240020 Hospitalet De Llobregat
Spain Investigational Site Number 7240006 La Coruña
Spain Investigational Site Number 7240005 Las Palmas De Gran Canaria
Spain Investigational Site Number 7240008 Madrid
Spain Investigational Site Number 7240021 Madrid
Spain Investigational Site Number 7240004 Málaga
Spain Investigational Site Number 7240022 Manises
Spain Investigational Site Number 7240007 Murcia
Spain Investigational Site Number 7240014 Olot
Spain Investigational Site Number 7240009 San Sebastián De Los Reyes
Spain Investigational Site Number 7240003 Sanlúcar De Barrameda
Spain Investigational Site Number 7240001 Sevilla
Spain Investigational Site Number 7240019 Sevilla
Spain Investigational Site Number 7240018 Úbeda
Spain Investigational Site Number 7240010 Valencia
Spain Investigational Site Number 7240011 Valencia
Spain Investigational Site Number 7240012 Valencia
Spain Investigational Site Number 7240002 Villamartín
Spain Investigational Site Number 7240013 Zaragoza
Sweden Investigational Site Number 7520004 Jönköping
Sweden Investigational Site Number 7520002 Malmö
Sweden Investigational Site Number 7520006 Skellefteå
Sweden Investigational Site Number 7520001 Stockholm
Sweden Investigational Site Number 7520007 Stockholm
Sweden Investigational Site Number 7520008 Stockholm
Switzerland Investigational Site Number 7560001 Basel
Switzerland Investigational Site Number 7560003 Lugano
Turkey Investigational Site Number 7920008 Antalya
Turkey Investigational Site Number 7920006 Corum
Turkey Investigational Site Number 7920005 Eskisehir
Turkey Investigational Site Number 7920002 Haseki/ Istanbul
Turkey Investigational Site Number 7920011 Istanbul
Turkey Investigational Site Number 7920012 Izmir
Turkey Investigational Site Number 7920003 Kocaeli
Turkey Investigational Site Number 7920004 Mersin
Turkey Investigational Site Number 7920001 Sivas
Turkey Investigational Site Number 7920010 Trabzon
United Kingdom Investigational Site Number 8260005 Bournemouth
United Kingdom Investigational Site Number 8260010 Bristol
United Kingdom Investigational Site Number 8260008 Chelmsford
United Kingdom Investigational Site Number 8260009 Hull
United Kingdom Investigational Site Number 8260002 Newcastle
United Kingdom Investigational Site Number 8260001 Oldham
United Kingdom Investigational Site Number 8260003 Swansea
United Kingdom Investigational Site Number 8260006 Swindon
United Kingdom Investigational Site Number 8260004 Torquay
United Kingdom Investigational Site Number 8260007 York
United States Investigational Site Number 8400131 Albuquerque New Mexico
United States Investigational Site Number 8400128 Alexander City Alabama
United States Investigational Site Number 8400065 Annapolis Maryland
United States Investigational Site Number 8400054 Arlington Oregon
United States Investigational Site Number 8400067 Arlington Heights Illinois
United States Investigational Site Number 8400073 Atlanta Georgia
United States Investigational Site Number 8400075 Bakersfield California
United States Investigational Site Number 8400012 Boston Massachusetts
United States Investigational Site Number 8400029 Bridgeport Connecticut
United States Investigational Site Number 8400061 Bronx New York
United States Investigational Site Number 8400097 Bronx New York
United States Investigational Site Number 8400051 Brooklyn New York
United States Investigational Site Number 8400041 Brownsville Texas
United States Investigational Site Number 8400111 Buffalo New York
United States Investigational Site Number 8400001 Cambridge Massachusetts
United States Investigational Site Number 8400059 Charleston South Carolina
United States Investigational Site Number 8400043 Chicago Illinois
United States Investigational Site Number 8400047 Cincinnati Ohio
United States Investigational Site Number 8400087 Cincinnati Ohio
United States Investigational Site Number 8400126 Clarksburg West Virginia
United States Investigational Site Number 8400019 Columbia Missouri
United States Investigational Site Number 8400092 Columbia South Carolina
United States Investigational Site Number 8400109 Cottonwood Arizona
United States Investigational Site Number 8400030 Covington Louisiana
United States Investigational Site Number 8400074 Dallas Texas
United States Investigational Site Number 8400046 DeLand Florida
United States Investigational Site Number 8400077 Detroit Michigan
United States Investigational Site Number 8400134 Doylestown Pennsylvania
United States Investigational Site Number 8400107 Duluth Minnesota
United States Investigational Site Number 8400072 Elk Grove Village Illinois
United States Investigational Site Number 8400069 Fresno California
United States Investigational Site Number 8400009 Gainesville Florida
United States Investigational Site Number 8400132 Grand Island Nebraska
United States Investigational Site Number 8400045 Greensboro North Carolina
United States Investigational Site Number 8400088 Greenville Tennessee
United States Investigational Site Number 8400104 Greenville South Carolina
United States Investigational Site Number 8400079 Homestead Florida
United States Investigational Site Number 8400016 Houston Texas
United States Investigational Site Number 8400055 Indianapolis Indiana
United States Investigational Site Number 8400056 Jackson Mississippi
United States Investigational Site Number 8400022 Jacksonville Florida
United States Investigational Site Number 8400031 Jacksonville Florida
United States Investigational Site Number 8400017 Kalamazoo Michigan
United States Investigational Site Number 8400062 Kalamazoo Michigan
United States Investigational Site Number 8400098 Lake Mary Florida
United States Investigational Site Number 8400103 Lee's Summit Missouri
United States Investigational Site Number 8400130 Lincoln Nebraska
United States Investigational Site Number 8400032 Little Rock Arkansas
United States Investigational Site Number 8400080 Little Rock Arkansas
United States Investigational Site Number 8400008 Los Angeles California
United States Investigational Site Number 8400063 Los Angeles California
United States Investigational Site Number 8400093 Manassas Virginia
United States Investigational Site Number 8400048 Manitowoc Wisconsin
United States Investigational Site Number 8400095 Maumee Ohio
United States Investigational Site Number 8400123 McKinney Texas
United States Investigational Site Number 8400089 Memphis Tennessee
United States Investigational Site Number 8400058 Miami Beach Florida
United States Investigational Site Number 8400038 Morgantown West Virginia
United States Investigational Site Number 8400020 Muncie Indiana
United States Investigational Site Number 8400053 Nashville Tennessee
United States Investigational Site Number 8400127 National City California
United States Investigational Site Number 8400044 Natrona Heights Pennsylvania
United States Investigational Site Number 8400101 New Braunfels Texas
United States Investigational Site Number 8400037 New Haven Connecticut
United States Investigational Site Number 8400071 Omaha Nebraska
United States Investigational Site Number 8400083 Omaha Nebraska
United States Investigational Site Number 8400105 Orlando Florida
United States Investigational Site Number 8400082 Pensacola Florida
United States Investigational Site Number 8400115 Philadelphia Pennsylvania
United States Investigational Site Number 8400057 Port Charlotte Florida
United States Investigational Site Number 8400114 Providence Rhode Island
United States Investigational Site Number 8400085 Raleigh North Carolina
United States Investigational Site Number 8400040 Rapid City South Dakota
United States Investigational Site Number 8400007 Redondo Beach California
United States Investigational Site Number 8400003 Richmond Virginia
United States Investigational Site Number 8400122 Richmond Indiana
United States Investigational Site Number 8400015 Ridgewood New Jersey
United States Investigational Site Number 8400006 Sarasota Florida
United States Investigational Site Number 8400039 Sayre Pennsylvania
United States Investigational Site Number 8400036 Stockton California
United States Investigational Site Number 8400033 Sylmar California
United States Investigational Site Number 8400035 Tampa Florida
United States Investigational Site Number 8400042 Tampa Florida
United States Investigational Site Number 8400099 Toledo Ohio
United States Investigational Site Number 8400049 Torrance California
United States Investigational Site Number 8400118 Tucker Georgia
United States Investigational Site Number 8400066 Victoria Texas
United States Investigational Site Number 8400050 Voorhees New Jersey
United States Investigational Site Number 8400028 Walnut Creek California
United States Investigational Site Number 8400100 Warwick Rhode Island
United States Investigational Site Number 8400091 Waterloo Iowa
United States Investigational Site Number 8400004 Wellington Florida
United States Investigational Site Number 8400078 Winston-Salem North Carolina
United States Investigational Site Number 8400121 Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Lexicon Pharmaceuticals Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 21.9 months
Secondary Total Number of Occurrences of HHF and Urgent HF Visits Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 21.9 months
Secondary Total Number of Deaths From Cardiovascular Causes Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 21.9 months
Secondary Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 21.9 months
Secondary Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 21.9 months
Secondary Total Number of Deaths From Any Cause Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up. Up to 21.9 months
Secondary Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4 KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis. Baseline to Month 4
Secondary Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m^2). A mixed model for repeated measures (MMRM) was used for analysis. Baseline up to 21.9 months
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy