Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Heart Failure Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03521934
• Other study ID #: EFC15156
• Secondary ID: 2017-003510-16U1
• Status: Terminated
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes Mellitus

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
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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