Acute Heart Failure (AHF) Clinical Trial
— RELAX-AHF-EUOfficial title:
A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
| Verified date | December 2018 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).
| Status | Terminated |
| Enrollment | 2666 |
| Est. completion date | April 25, 2017 |
| Est. primary completion date | March 26, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Systolic blood pressure = 125 mmHg - Admitted for Acute Heart Failure (AHF) - Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening - eGFR on admission: = 25 and =75 mL/min/1.73 m^2 Exclusion Criteria: - Dyspnea (non-cardiac causes) - T > 38.5°C - Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment. - Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis. - AHF due to significant arrhythmias - Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function). |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novartis Investigative Site | Feldkirch | |
| Austria | Novartis Investigative Site | Graz | |
| Austria | Novartis Investigative Site | Linz | |
| Austria | Novartis Investigative Site | Salzburg | |
| Austria | Novartis Investigative Site | Salzburg | |
| Austria | Novartis Investigative Site | St. Poelten | |
| Austria | Novartis Investigative Site | Vienna | |
| Austria | Novartis Investigative Site | Vienna | |
| Austria | Novartis Investigative Site | Wien | |
| Belgium | Novartis Investigative Site | Aalst | |
| Belgium | Novartis Investigative Site | Brugge | |
| Belgium | Novartis Investigative Site | Brussel | |
| Belgium | Novartis Investigative Site | Gent | |
| Belgium | Novartis Investigative Site | Hasselt | |
| Belgium | Novartis Investigative Site | Leuven | |
| Belgium | Novartis Investigative Site | Liege | |
| Belgium | Novartis Investigative Site | Lodelinsart | |
| Belgium | Novartis Investigative Site | Mol | |
| Belgium | Novartis Investigative Site | Mons | |
| Belgium | Novartis Investigative Site | Roeselare | |
| Belgium | Novartis Investigative Site | Ronse | |
| Belgium | Novartis Investigative Site | Turnhout | |
| Bulgaria | Novartis Investigative Site | Gabrovo | |
| Bulgaria | Novartis Investigative Site | Plovdiv | |
| Bulgaria | Novartis Investigative Site | Ruse | |
| Bulgaria | Novartis Investigative Site | Sliven | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Veliko Tarnovo | |
| Croatia | Novartis Investigative Site | Varazdin | HRV |
| Croatia | Novartis Investigative Site | Zagreb | |
| Czechia | Novartis Investigative Site | Brno | Czech Republic |
| Czechia | Novartis Investigative Site | Decin II | Czech Republic |
| Czechia | Novartis Investigative Site | Karvina-Raj | Czech Republic |
| Czechia | Novartis Investigative Site | Kromeriz | Czech Republic |
| Czechia | Novartis Investigative Site | Melnik | Czech Republic |
| Czechia | Novartis Investigative Site | Pisek | Czech Republic |
| Czechia | Novartis Investigative Site | Plzen | |
| Czechia | Novartis Investigative Site | Prague 5 | |
| Czechia | Novartis Investigative Site | Svitavy | Czech Republic |
| Czechia | Novartis Investigative Site | Tabor | Czech Republic |
| Czechia | Novartis Investigative Site | Trebic | Czech Republic |
| Estonia | Novartis Investigative Site | Tallinn | |
| Estonia | Novartis Investigative Site | Tartu | |
| Finland | Novartis Investigative Site | Turku | |
| France | Novartis Investigative Site | Abbeville | |
| France | Novartis Investigative Site | Agen Cedex 9 | |
| France | Novartis Investigative Site | Amiens cedex 1 | |
| France | Novartis Investigative Site | Avignon | |
| France | Novartis Investigative Site | Belfort | |
| France | Novartis Investigative Site | Besancon Cedex | |
| France | Novartis Investigative Site | Brest | |
| France | Novartis Investigative Site | Bron | |
| France | Novartis Investigative Site | Chalon sur Saône | |
| France | Novartis Investigative Site | Chambray-lès-Tours | |
| France | Novartis Investigative Site | Chateauroux | |
| France | Novartis Investigative Site | Clermont-Ferrand | |
| France | Novartis Investigative Site | Corbeil Essonnes | |
| France | Novartis Investigative Site | Dunkerque | |
| France | Novartis Investigative Site | La Seyne sur mer | |
| France | Novartis Investigative Site | Le Coudray | |
| France | Novartis Investigative Site | Le Mans Cedex 09 | |
| France | Novartis Investigative Site | Lens | |
| France | Novartis Investigative Site | Limoges Cedex | |
| France | Novartis Investigative Site | Lorient Cedex | |
| France | Novartis Investigative Site | Marseille cedex 20 | Bouches Du Rhone |
| France | Novartis Investigative Site | Metz | |
| France | Novartis Investigative Site | Montauban | |
| France | Novartis Investigative Site | Montauban | |
| France | Novartis Investigative Site | Montpellier | |
| France | Novartis Investigative Site | Mulhouse cedex | |
| France | Novartis Investigative Site | Nancy | Cedex |
| France | Novartis Investigative Site | Nimes Cedex 09 | |
| France | Novartis Investigative Site | Niort | |
| France | Novartis Investigative Site | Orleans | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris cedex 10 | |
| France | Novartis Investigative Site | Pau | |
| France | Novartis Investigative Site | Périgueux | |
| France | Novartis Investigative Site | Poitiers | |
| France | Novartis Investigative Site | Rennes Cedex 9 | |
| France | Novartis Investigative Site | Saint Brieuc | |
| France | Novartis Investigative Site | St Michel | |
| France | Novartis Investigative Site | St Priest en Jarez Cedex | |
| France | Novartis Investigative Site | Strasbourg Cedex | |
| France | Novartis Investigative Site | Troyes | |
| France | Novartis Investigative Site | Vienne | |
| Germany | Novartis Investigative Site | Arnstadt | |
| Germany | Novartis Investigative Site | Bad Berka | |
| Germany | Novartis Investigative Site | Bad Oeynhausen | |
| Germany | Novartis Investigative Site | Baden-Baden | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bernburg | |
| Germany | Novartis Investigative Site | Bochum | |
| Germany | Novartis Investigative Site | Buchholz in der Nordheide | |
| Germany | Novartis Investigative Site | Chemnitz | |
| Germany | Novartis Investigative Site | Chemnitz | |
| Germany | Novartis Investigative Site | Dorsten | |
| Germany | Novartis Investigative Site | Dortmund | |
| Germany | Novartis Investigative Site | Dortmund | |
| Germany | Novartis Investigative Site | Dortmund | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Duisburg | |
| Germany | Novartis Investigative Site | Duisburg | |
| Germany | Novartis Investigative Site | Düssledorf | |
| Germany | Novartis Investigative Site | Erfurt | |
| Germany | Novartis Investigative Site | Erfurt | |
| Germany | Novartis Investigative Site | Erlangen | |
| Germany | Novartis Investigative Site | Eschwege | |
| Germany | Novartis Investigative Site | Esslingen | |
| Germany | Novartis Investigative Site | Flensburg | Schleswig Holstein |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Friesoythe | |
| Germany | Novartis Investigative Site | Gera | |
| Germany | Novartis Investigative Site | Gotha | |
| Germany | Novartis Investigative Site | Greifswald | |
| Germany | Novartis Investigative Site | Guetersloh | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Heidelberg | |
| Germany | Novartis Investigative Site | Heidenheim | |
| Germany | Novartis Investigative Site | Hennigsdorf | |
| Germany | Novartis Investigative Site | Herford | |
| Germany | Novartis Investigative Site | Hoyerswerda | |
| Germany | Novartis Investigative Site | Kaufbeuren | |
| Germany | Novartis Investigative Site | Koblenz | |
| Germany | Novartis Investigative Site | Koeln-Nippes | |
| Germany | Novartis Investigative Site | Langen | |
| Germany | Novartis Investigative Site | Lemgo | |
| Germany | Novartis Investigative Site | Leverkusen | |
| Germany | Novartis Investigative Site | Lüneburg | |
| Germany | Novartis Investigative Site | Mannheim | |
| Germany | Novartis Investigative Site | Marburg | |
| Germany | Novartis Investigative Site | Marl | |
| Germany | Novartis Investigative Site | Memmingen | |
| Germany | Novartis Investigative Site | Moenchengladbach | |
| Germany | Novartis Investigative Site | Muelheim | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | Neumünster | |
| Germany | Novartis Investigative Site | Neunkirchen | |
| Germany | Novartis Investigative Site | Neuss | |
| Germany | Novartis Investigative Site | Neustadt A.d. Aisch | |
| Germany | Novartis Investigative Site | Neuwied | |
| Germany | Novartis Investigative Site | Nürnberg | |
| Germany | Novartis Investigative Site | Ribnitz-Damgarten | |
| Germany | Novartis Investigative Site | Rostock | |
| Germany | Novartis Investigative Site | Rotenburg | |
| Germany | Novartis Investigative Site | Schoenebeck | |
| Germany | Novartis Investigative Site | Schwabach | |
| Germany | Novartis Investigative Site | Schwalmstadt | |
| Germany | Novartis Investigative Site | Singen | |
| Germany | Novartis Investigative Site | Soest | |
| Germany | Novartis Investigative Site | Sonneberg | |
| Germany | Novartis Investigative Site | Speyer | |
| Germany | Novartis Investigative Site | Stade | |
| Germany | Novartis Investigative Site | Stadtlohn | |
| Germany | Novartis Investigative Site | Stuttgart | |
| Germany | Novartis Investigative Site | Suhl | |
| Germany | Novartis Investigative Site | Torgau | |
| Germany | Novartis Investigative Site | Trier | |
| Germany | Novartis Investigative Site | Tuebingen | |
| Germany | Novartis Investigative Site | Ulm | |
| Germany | Novartis Investigative Site | Vechta | |
| Germany | Novartis Investigative Site | Wesel | |
| Germany | Novartis Investigative Site | Witten | |
| Germany | Novartis Investigative Site | Worms | |
| Germany | Novartis Investigative Site | Wuerzburg | |
| Germany | Novartis Investigative Site | Wuppertal | |
| Germany | Novartis Investigative Site | Wurzen | |
| Greece | Novartis Investigative Site | Alexandroupolis | Evros |
| Greece | Novartis Investigative Site | Athens | |
| Greece | Novartis Investigative Site | Athens | |
| Greece | Novartis Investigative Site | Athens | |
| Greece | Novartis Investigative Site | Volos | |
| Greece | Novartis Investigative Site | Voula | GR |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Debrecen | |
| Hungary | Novartis Investigative Site | Eger | |
| Hungary | Novartis Investigative Site | Gyor | |
| Hungary | Novartis Investigative Site | Kalocsa | |
| Hungary | Novartis Investigative Site | Kecskemet | |
| Hungary | Novartis Investigative Site | Kistarcsa | |
| Hungary | Novartis Investigative Site | Mako | |
| Hungary | Novartis Investigative Site | Szeged | |
| Hungary | Novartis Investigative Site | Szolnok | |
| Iceland | Novartis Investigative Site | Reykjavik | |
| Italy | Novartis Investigative Site | Acquaviva delle Fonti | BA |
| Italy | Novartis Investigative Site | Altamura | BA |
| Italy | Novartis Investigative Site | Arezzo | AR |
| Italy | Novartis Investigative Site | Busto Arsizio | VA |
| Italy | Novartis Investigative Site | Cagliari | CA |
| Italy | Novartis Investigative Site | Cassano delle Murge | BA |
| Italy | Novartis Investigative Site | Catania | CT |
| Italy | Novartis Investigative Site | Cernusco sul Naviglio | MI |
| Italy | Novartis Investigative Site | Chioggia | VE |
| Italy | Novartis Investigative Site | Latina | LT |
| Italy | Novartis Investigative Site | Legnano | MI |
| Italy | Novartis Investigative Site | Lodi | LO |
| Italy | Novartis Investigative Site | Matera | Mount |
| Italy | Novartis Investigative Site | Messina | ME |
| Italy | Novartis Investigative Site | Orbassano | TO |
| Italy | Novartis Investigative Site | Piacenza | PC |
| Italy | Novartis Investigative Site | Pordenone | PN |
| Italy | Novartis Investigative Site | Pozzuoli | |
| Italy | Novartis Investigative Site | Reggio Emilia | RE |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | San Benedetto del Tronto | AP |
| Italy | Novartis Investigative Site | Sassari | SS |
| Italy | Novartis Investigative Site | Scandiano | RE |
| Italy | Novartis Investigative Site | Siena | SI |
| Italy | Novartis Investigative Site | Siracusa | SR |
| Italy | Novartis Investigative Site | Torino | TO |
| Italy | Novartis Investigative Site | Torino | TO |
| Italy | Novartis Investigative Site | Treviglio | BG |
| Italy | Novartis Investigative Site | Verona | VR |
| Italy | Novartis Investigative Site | Vibo Valentia | VV |
| Italy | Novartis Investigative Site | Vicenza | VI |
| Latvia | Novartis Investigative Site | Daugavpils | |
| Lithuania | Novartis Investigative Site | Kaunas | LTU |
| Lithuania | Novartis Investigative Site | Kaunas | LT |
| Lithuania | Novartis Investigative Site | Klaipeda | |
| Lithuania | Novartis Investigative Site | Vilnius | |
| Poland | Novartis Investigative Site | Bilgoraj | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Grodzisk Mazowiecki | |
| Poland | Novartis Investigative Site | Kielce | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Krakow | POL |
| Poland | Novartis Investigative Site | Lubin | |
| Poland | Novartis Investigative Site | Lublin | |
| Poland | Novartis Investigative Site | Oswiecim | |
| Poland | Novartis Investigative Site | Rzeszow | |
| Poland | Novartis Investigative Site | Tarnobrzeg | |
| Poland | Novartis Investigative Site | Tarnow | |
| Poland | Novartis Investigative Site | Walbrzych | |
| Portugal | Novartis Investigative Site | Almada | |
| Portugal | Novartis Investigative Site | Barreiro | |
| Portugal | Novartis Investigative Site | Braga | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Matosinhos | |
| Portugal | Novartis Investigative Site | Setubal | |
| Portugal | Novartis Investigative Site | Vila Franca de Xira | |
| Romania | Novartis Investigative Site | Bucharest | Jud Cluj |
| Romania | Novartis Investigative Site | Bucharest | |
| Romania | Novartis Investigative Site | Bucuresti | District 4 |
| Romania | Novartis Investigative Site | Craiova | Jud. Iasi |
| Romania | Novartis Investigative Site | Sibiu | |
| Romania | Novartis Investigative Site | Tirgoviste | |
| Russian Federation | Novartis Investigative Site | Chelyabinsk | |
| Russian Federation | Novartis Investigative Site | Chelyabinsk | |
| Russian Federation | Novartis Investigative Site | Chita | |
| Russian Federation | Novartis Investigative Site | Gatchina | |
| Russian Federation | Novartis Investigative Site | Izhevsk | |
| Russian Federation | Novartis Investigative Site | Kazan | |
| Russian Federation | Novartis Investigative Site | Kazan | |
| Russian Federation | Novartis Investigative Site | Kirov | |
| Russian Federation | Novartis Investigative Site | Krasnoyarsk | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Novosibirsk | |
| Russian Federation | Novartis Investigative Site | Penza | |
| Russian Federation | Novartis Investigative Site | Petrozavodsk | |
| Russian Federation | Novartis Investigative Site | Rostov-on-Don | |
| Russian Federation | Novartis Investigative Site | Ryazan | |
| Russian Federation | Novartis Investigative Site | Saint-Petersburg | |
| Russian Federation | Novartis Investigative Site | Saratov | |
| Russian Federation | Novartis Investigative Site | St.-Petersburg | |
| Russian Federation | Novartis Investigative Site | Tyumen | |
| Russian Federation | Novartis Investigative Site | Ufa | |
| Russian Federation | Novartis Investigative Site | Vladivostok | |
| Russian Federation | Novartis Investigative Site | Volgograd | |
| Russian Federation | Novartis Investigative Site | Yaroslavl | |
| Russian Federation | Novartis Investigative Site | Zelenograd, Moscow Region | |
| Serbia | Novartis Investigative Site | Belgrade | |
| Serbia | Novartis Investigative Site | Belgrade | |
| Serbia | Novartis Investigative Site | Belgrade | |
| Serbia | Novartis Investigative Site | Kamenica | |
| Serbia | Novartis Investigative Site | Nis | |
| Serbia | Novartis Investigative Site | Niska Banja | |
| Slovakia | Novartis Investigative Site | Brezno | |
| Slovakia | Novartis Investigative Site | Dunajska Streda | Slovak Republic |
| Slovakia | Novartis Investigative Site | Poprad | |
| Slovakia | Novartis Investigative Site | Skalica | Slovak Republic |
| Slovakia | Novartis Investigative Site | Trencin | |
| Slovakia | Novartis Investigative Site | Zvolen | Slovak Republic |
| Slovenia | Novartis Investigative Site | Celje | |
| Slovenia | Novartis Investigative Site | Jesenice | |
| Slovenia | Novartis Investigative Site | Ljubljana | |
| Slovenia | Novartis Investigative Site | Murska Sobota | |
| Spain | Novartis Investigative Site | Alcorcon | Madrid |
| Spain | Novartis Investigative Site | Alicante | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Alicante | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Alzira | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Bilbao | Pais Vasco |
| Spain | Novartis Investigative Site | Caceres | Extremadura |
| Spain | Novartis Investigative Site | Cartagena | Murcia |
| Spain | Novartis Investigative Site | El Palmar | Murcia |
| Spain | Novartis Investigative Site | Fuenlabrada | Madrid |
| Spain | Novartis Investigative Site | Galdakano | Pais Vasco |
| Spain | Novartis Investigative Site | Granada | Andalucia |
| Spain | Novartis Investigative Site | Granada | Andalucia |
| Spain | Novartis Investigative Site | La Coruna | Galicia |
| Spain | Novartis Investigative Site | La Laguna | Santa Cruz De Tenerife |
| Spain | Novartis Investigative Site | Las Palmas de Gran Canaria | Las Palmas De G.C |
| Spain | Novartis Investigative Site | Leon | |
| Spain | Novartis Investigative Site | Lleida | Cataluna |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Spain | Novartis Investigative Site | Manises | Valencia |
| Spain | Novartis Investigative Site | Murcia | |
| Spain | Novartis Investigative Site | Oviedo | Asturias |
| Spain | Novartis Investigative Site | Salamanca | Castilla Y Leon |
| Spain | Novartis Investigative Site | Sanlucar de Barrameda | Andalucia |
| Spain | Novartis Investigative Site | Santiago de Compostela | Galicia |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Soria | Castilla Y Leon |
| Spain | Novartis Investigative Site | Terrassa | Catalunya |
| Spain | Novartis Investigative Site | Toledo | Castilla La Mancha |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Villamartin | Cadiz |
| Spain | Novartis Investigative Site | Zaragoza | |
| Switzerland | Novartis Investigative Site | Basel | |
| Switzerland | Novartis Investigative Site | Geneve 14 | |
| Switzerland | Novartis Investigative Site | Liestal | |
| Switzerland | Novartis Investigative Site | Lugano | |
| United Kingdom | Novartis Investigative Site | Barnet | |
| United Kingdom | Novartis Investigative Site | Cardiff | |
| United Kingdom | Novartis Investigative Site | Dorchester | Dorset |
| United Kingdom | Novartis Investigative Site | Dundee | |
| United Kingdom | Novartis Investigative Site | Durham | County Durham |
| United Kingdom | Novartis Investigative Site | Gateshead | Tyne And Wear |
| United Kingdom | Novartis Investigative Site | Liverpool | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Peterborough | GBR |
| United Kingdom | Novartis Investigative Site | Swindon |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Austria, Belgium, Bulgaria, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 | In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication. | 5 days | |
| Secondary | Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 | WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators. | 14 days | |
| Secondary | Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 | Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5. | 5 days | |
| Secondary | Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 | Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine. | 14 days | |
| Secondary | Length of Index Hospital Stay | Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time. | 30 Days | |
| Secondary | Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients | Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days | ||
| Secondary | Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire. | EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state). | Baseline, Day 5, Day 14 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05042752 -
Impact of Clinical Ultrasound in Patients With Heart Failure Treated in Home Hospitalization
|
N/A |