AzTrials
AzTrials

Acute Heart Failure (AHF)Phase 3RELAX-AHF-EUNCT02064868

Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

A Phase 3 study testing Serelaxin in people with Acute Heart Failure (AHF), run by Novartis Pharmaceuticals at 357 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure (AHF)
What is being tested?
Serelaxin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,666 participants
Where
357 sitesin 25 countries
Study dates
31 Jan 2014to 25 Apr 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

357 sites in 25 countries.

357 sites in 25 countries

Germany86 sites

  • Novartis Investigative Site

    Arnstadt, 99310

  • Novartis Investigative Site

    Bad Berka, 99438

  • Novartis Investigative Site

    Bad Oeynhausen, 32545

  • Novartis Investigative Site

    Baden-Baden, 76532

  • Novartis Investigative Site

    Berlin, 10405

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 12526

  • Novartis Investigative Site

    Berlin, 12683

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Bernburg, 06406

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Buchholz in der Nordheide, 21244

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Dorsten, 46282

  • Novartis Investigative Site

    Dortmund, 44263

  • Novartis Investigative Site

    Dortmund, 44309

  • Novartis Investigative Site

    Dortmund, 44379

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Duisburg, 47137

  • Novartis Investigative Site

    Duisburg, 47228

  • Novartis Investigative Site

    Düssledorf, 40217

  • Novartis Investigative Site

    Erfurt, 99089

  • Novartis Investigative Site

    Erfurt, 99097

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Eschwege, 37269

  • Novartis Investigative Site

    Esslingen am Neckar, 73730

  • Novartis Investigative Site

    Flensburg, Schleswig-Holstein, 24939

  • Novartis Investigative Site

    Frankfurt, 60316

  • Novartis Investigative Site

    Frankfurt, 65929

  • Novartis Investigative Site

    Friesoythe, 26169

  • Novartis Investigative Site

    Gera, 07548

  • Novartis Investigative Site

    Gotha, 99867

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Gütersloh, 33332

  • Novartis Investigative Site

    Hamburg, 22457

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Heidenheim, 89522

  • Novartis Investigative Site

    Hennigsdorf, 16761

  • Novartis Investigative Site

    Herford, 32049

  • Novartis Investigative Site

    Hoyerswerda, 02977

  • Novartis Investigative Site

    Kaufbeuren, 87600

  • Novartis Investigative Site

    Koblenz, 56073

  • Novartis Investigative Site

    Koeln-Nippes, 50733

  • Novartis Investigative Site

    Langen, 63225

  • Novartis Investigative Site

    Lemgo, 32657

  • Novartis Investigative Site

    Leverkusen, 51379

  • Novartis Investigative Site

    Lüneburg, 21339

  • Novartis Investigative Site

    Mannheim, 68167

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    Marl, 45768

  • Novartis Investigative Site

    Memmingen, 87700

  • Novartis Investigative Site

    Mönchengladbach, 41063

  • Novartis Investigative Site

    Mülheim, 45468

  • Novartis Investigative Site

    München, 81379

  • Novartis Investigative Site

    Neumünster, 24534

  • Novartis Investigative Site

    Neunkirchen, 66538

  • Novartis Investigative Site

    Neuss, 41464

  • Novartis Investigative Site

    Neustadt A.d. Aisch, 91413

  • Novartis Investigative Site

    Neuwied, 56564

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Ribnitz-Damgarten, 18311

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Rotenburg (Wümme), 27356

  • Novartis Investigative Site

    Schönebeck, 39218

  • Novartis Investigative Site

    Schwabach, 91126

  • Novartis Investigative Site

    Schwalmstadt, 34613

  • Novartis Investigative Site

    Singen, 78224

  • Novartis Investigative Site

    Soest, 59494

  • Novartis Investigative Site

    Sonneberg, 96515

  • Novartis Investigative Site

    Speyer, 67346

  • Novartis Investigative Site

    Stade, 21682

  • Novartis Investigative Site

    Stadtlohn, 48703

  • Novartis Investigative Site

    Stuttgart, 70376

  • Novartis Investigative Site

    Suhl, 98527

  • Novartis Investigative Site

    Torgau, 04860

  • Novartis Investigative Site

    Trier, 54292

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Vechta, 49377

  • Novartis Investigative Site

    Wesel, 46483

  • Novartis Investigative Site

    Witten, 58455

  • Novartis Investigative Site

    Worms, 67550

  • Novartis Investigative Site

    Wuppertal, 42109

  • Novartis Investigative Site

    Würzburg, 97078

  • Novartis Investigative Site

    Wurzen, 04808

Other trials in Germany

France43 sites

  • Novartis Investigative Site

    Abbeville, 80100

  • Novartis Investigative Site

    Agen, 47923

  • Novartis Investigative Site

    Amiens, 80054

  • Novartis Investigative Site

    Avignon, 84000

  • Novartis Investigative Site

    Belfort, 90 016

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Bron, 69677

  • Novartis Investigative Site

    Chalon-sur-Saône, 71321

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170

  • Novartis Investigative Site

    Châteauroux, 36000

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Dunkirk, 59385

  • Novartis Investigative Site

    La Seyne-sur-Mer, 83500

  • Novartis Investigative Site

    Le Coudray, 28630

  • Novartis Investigative Site

    Le Mans, 72037

  • Novartis Investigative Site

    Lens, 62307

  • Novartis Investigative Site

    Limoges, 87042

  • Novartis Investigative Site

    Lorient, 56322

  • Novartis Investigative Site

    Marseille, Bouches Du Rhone, 13915

  • Novartis Investigative Site

    Metz, 57085

  • Novartis Investigative Site

    Montauban, 82013

  • Novartis Investigative Site

    Montauban, 82017

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Mulhouse, 68070

  • Novartis Investigative Site

    Nancy, Cedex, 54035

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Niort, 79021

  • Novartis Investigative Site

    Orléans, 45100

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Pau, 64000

  • Novartis Investigative Site

    Périgueux, 24019

  • Novartis Investigative Site

    Poitiers, 86021

  • Novartis Investigative Site

    Rennes, 35033

  • Novartis Investigative Site

    Saint-Brieuc, 22027

  • Novartis Investigative Site

    Saint-Michel-sur-Orge, 16470

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42277

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Troyes, 10003

  • Novartis Investigative Site

    Vienne, 38209

Other trials in France

Spain39 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Alicante, Valencia, 03550

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

  • Novartis Investigative Site

    Cartagena, Murcia, 30202

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Fuenlabrada, Madrid, 28942

  • Novartis Investigative Site

    Galdakano, Basque Country, 48960

  • Novartis Investigative Site

    Granada, Andalusia, 18012

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, Las Palmas de G.C, 35010

  • Novartis Investigative Site

    León, 24080

  • Novartis Investigative Site

    Lleida, Catalonia, 25198

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Manises, Valencia, 46940

  • Novartis Investigative Site

    Murcia, 30003

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Sanlúcar de Barrameda, Andalusia, 11540

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Soria, Castille and León, 42005

  • Novartis Investigative Site

    Terrassa, Catalonia, 08227

  • Novartis Investigative Site

    Toledo, Castille-La Mancha, 45071

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Valencia, Valencia, 46015

  • Novartis Investigative Site

    Valencia, Valencia, 46017

  • Novartis Investigative Site

    Villamartín, Cadiz, 11650

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Italy34 sites

  • Novartis Investigative Site

    Acquaviva delle Fonti, BA, 70021

  • Novartis Investigative Site

    Altamura, BA, 70022

  • Novartis Investigative Site

    Arezzo, AR, 52100

  • Novartis Investigative Site

    Busto Arsizio, VA, 21052

  • Novartis Investigative Site

    Cagliari, CA, 09134

  • Novartis Investigative Site

    Cassano delle Murge, BA, 70020

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Cernusco sul Naviglio, MI, 20063

  • Novartis Investigative Site

    Chioggia, VE, 30015

  • Novartis Investigative Site

    Latina, LT, 04100

  • Novartis Investigative Site

    Legnano, MI, 20025

  • Novartis Investigative Site

    Lodi, LO, 26900

  • Novartis Investigative Site

    Matera, Mount, 75100

  • Novartis Investigative Site

    Messina, ME, 98125

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Piacenza, PC, 29100

  • Novartis Investigative Site

    Pordenone, PN, 33170

  • Novartis Investigative Site

    Pozzuoli, 80078

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Roma, RM, 00135

  • Novartis Investigative Site

    Roma, RM, 00152

  • Novartis Investigative Site

    Roma, RM, 00177

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    San Benedetto del Tronto, AP, 63039

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Scandiano, RE, 42019

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Syracuse, SR, 96100

  • Novartis Investigative Site

    Torino, TO, 10153

  • Novartis Investigative Site

    Torino, TO, 10154

  • Novartis Investigative Site

    Treviglio, BG, 24047

  • Novartis Investigative Site

    Verona, VR, 37134

  • Novartis Investigative Site

    Vibo Valentia, VV, 89900

  • Novartis Investigative Site

    Vicenza, VI, 36100

Other trials in Italy

Russia27 sites

  • Novartis Investigative Site

    Chelyabinsk, 454000

  • Novartis Investigative Site

    Chelyabinsk, 454092

  • Novartis Investigative Site

    Chita, 672039

  • Novartis Investigative Site

    Gatchina, 188300

  • Novartis Investigative Site

    Izhevsk, 426009

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Kazan', 420103

  • Novartis Investigative Site

    Kirov, 610027

  • Novartis Investigative Site

    Krasnoyarsk, 660022

  • Novartis Investigative Site

    Moscow, 115280

  • Novartis Investigative Site

    Moscow, 117997

  • Novartis Investigative Site

    Moscow, 121359

  • Novartis Investigative Site

    Moscow, 127473

  • Novartis Investigative Site

    Moscow, 127994

  • Novartis Investigative Site

    Novosibirsk, 630003

  • Novartis Investigative Site

    Penza, 440026

  • Novartis Investigative Site

    Petrozavodsk, 185031

  • Novartis Investigative Site

    Rostov-on-Don, 344068

  • Novartis Investigative Site

    Ryazan, 390026

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saratov, 410028

  • Novartis Investigative Site

    Tyumen, 625023

  • Novartis Investigative Site

    Ufa, 450071

  • Novartis Investigative Site

    Vladivostok, 690002

  • Novartis Investigative Site

    Volgograd, 400008

  • Novartis Investigative Site

    Yaroslavl, 150047

  • Novartis Investigative Site

    Zelenograd, Moscow Region, 124489

Other trials in Russia

Poland14 sites

  • Novartis Investigative Site

    Biłgoraj, 23-400

  • Novartis Investigative Site

    Gdansk, 80 952

  • Novartis Investigative Site

    Grodzisk Mazowiecki, 05-825

  • Novartis Investigative Site

    Kielce, 25-317

  • Novartis Investigative Site

    Krakow, POL, 31-121

  • Novartis Investigative Site

    Krakow, 30-901

  • Novartis Investigative Site

    Krakow, 31 501

  • Novartis Investigative Site

    Lubin, 59-301

  • Novartis Investigative Site

    Lublin, 20-718

  • Novartis Investigative Site

    Oświęcim, 32-600

  • Novartis Investigative Site

    Rzeszów, 35-241

  • Novartis Investigative Site

    Tarnobrzeg, 39-400

  • Novartis Investigative Site

    Tarnów, 33-100

  • Novartis Investigative Site

    Wałbrzych, 58-309

Other trials in Poland

Belgium13 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Lodelinsart, 6042

  • Novartis Investigative Site

    Mol, 2400

  • Novartis Investigative Site

    Mons, 7000

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Ronse, 9600

  • Novartis Investigative Site

    Turnhout, 2300

Other trials in Belgium

Hungary13 sites

  • Novartis Investigative Site

    Budapest, 1096

  • Novartis Investigative Site

    Budapest, H 1096

  • Novartis Investigative Site

    Budapest, H-1032

  • Novartis Investigative Site

    Budapest, H-1115

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Eger, H-3300

  • Novartis Investigative Site

    Győr, H-9023

  • Novartis Investigative Site

    Kalocsa, 6300

  • Novartis Investigative Site

    Kecskemét, 6000

  • Novartis Investigative Site

    Kistarcsa, 2143

  • Novartis Investigative Site

    Makó, 6900

  • Novartis Investigative Site

    Szeged, H-6725

  • Novartis Investigative Site

    Szolnok, 5004

Other trials in Hungary

Czechia11 sites

  • Novartis Investigative Site

    Brno, Czech Republic, 656 91

  • Novartis Investigative Site

    Decin II, Czech Republic, 405 99

  • Novartis Investigative Site

    Karvina-Raj, Czech Republic, 73412

  • Novartis Investigative Site

    Kroměříž, Czech Republic, 767 55

  • Novartis Investigative Site

    Mělník, Czech Republic, 27601

  • Novartis Investigative Site

    Pilsen, 301 00

  • Novartis Investigative Site

    Písek, Czech Republic, 39701

  • Novartis Investigative Site

    Prague, 150 06

  • Novartis Investigative Site

    Svitavy, Czech Republic, 568 25

  • Novartis Investigative Site

    Tábor, Czech Republic, 39003

  • Novartis Investigative Site

    Třebíč, Czech Republic, 674 01

Other trials in Czechia

United Kingdom10 sites

  • Novartis Investigative Site

    Barnet, EN5 3DJ

  • Novartis Investigative Site

    Cardiff, CF14 4XW

  • Novartis Investigative Site

    Dorchester, Dorset, DT1 2JY

  • Novartis Investigative Site

    Dundee, DD1 9SY

  • Novartis Investigative Site

    Durham, County Durham, DH1 5TW

  • Novartis Investigative Site

    Gateshead, Tyne and Wear, NE9 6SX

  • Novartis Investigative Site

    Liverpool, L9 7AL

  • Novartis Investigative Site

    London, SW17 ORE

  • Novartis Investigative Site

    Peterborough, GBR, PE3 6DA

  • Novartis Investigative Site

    Swindon, SN3 6BB

Other trials in United Kingdom

Austria9 sites

  • Novartis Investigative Site

    Feldkirch, A-6807

  • Novartis Investigative Site

    Graz, 8020

  • Novartis Investigative Site

    Linz, A-4020

  • Novartis Investigative Site

    Salzburg, 5010

  • Novartis Investigative Site

    Salzburg, A-5020

  • Novartis Investigative Site

    Sankt Pölten, 3100

  • Novartis Investigative Site

    Vienna, 1130

  • Novartis Investigative Site

    Vienna, A-1020

  • Novartis Investigative Site

    Vienna, A-1160

Other trials in Austria

Portugal8 sites

  • Novartis Investigative Site

    Almada, 2801 951

  • Novartis Investigative Site

    Barreiro, 2834-003

  • Novartis Investigative Site

    Braga, 4710243

  • Novartis Investigative Site

    Lisbon, 1495-005

  • Novartis Investigative Site

    Lisbon, 1500 650

  • Novartis Investigative Site

    Matosinhos Municipality, 4454-509

  • Novartis Investigative Site

    Setúbal, 2910-446

  • Novartis Investigative Site

    Vila Franca de Xira, 2600-009

Other trials in Portugal

Bulgaria7 sites

  • Novartis Investigative Site

    Gabrovo, 5300

  • Novartis Investigative Site

    Plovdiv, 4000

  • Novartis Investigative Site

    Rousse, 7002

  • Novartis Investigative Site

    Sliven, 8800

  • Novartis Investigative Site

    Sofia, 1233

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Greece6 sites

  • Novartis Investigative Site

    Alexandroupoli, Evros, 681 00

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Volos, GR 38222

  • Novartis Investigative Site

    Voula, GR, 166 73

Other trials in Greece

Romania6 sites

  • Novartis Investigative Site

    Bucharest, District 4, 4204179

  • Novartis Investigative Site

    Bucharest, Jud Cluj, 010825

  • Novartis Investigative Site

    Bucharest, 022322

  • Novartis Investigative Site

    Craiova, Jud. Iasi, 200642

  • Novartis Investigative Site

    Sibiu, 550245

  • Novartis Investigative Site

    Targoviste, 130095

Other trials in Romania

Serbia6 sites

  • Novartis Investigative Site

    Belgrade, 11 000

  • Novartis Investigative Site

    Belgrade, 11000

  • Novartis Investigative Site

    Belgrade, 11080

  • Novartis Investigative Site

    Kamenica, 21204

  • Novartis Investigative Site

    Niš, 18000

  • Novartis Investigative Site

    Niška Banja, 18205

Other trials in Serbia

Slovakia6 sites

  • Novartis Investigative Site

    Brezno, 97701

  • Novartis Investigative Site

    Dunajská Streda, Slovak Republic, 92901

  • Novartis Investigative Site

    Poprad, 05845

  • Novartis Investigative Site

    Skalica, Slovak Republic, 909 82

  • Novartis Investigative Site

    Trenčín, 91171

  • Novartis Investigative Site

    Zvolen, Slovak Republic, 96001

Other trials in Slovakia

Lithuania4 sites

  • Novartis Investigative Site

    Kaunas, LTU, LT-50161

  • Novartis Investigative Site

    Kaunas, LT, LT-45130

  • Novartis Investigative Site

    Klaipėda, 92288

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Slovenia4 sites

  • Novartis Investigative Site

    Celje, 3000

  • Novartis Investigative Site

    Jesenice, 4270

  • Novartis Investigative Site

    Ljubljana, 1000

  • Novartis Investigative Site

    Murska Sobota, 9000

Other trials in Slovenia

Switzerland4 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Geneva, 1211

  • Novartis Investigative Site

    Liestal, 4410

  • Novartis Investigative Site

    Lugano, 6903

Other trials in Switzerland

Croatia2 sites

  • Novartis Investigative Site

    Varaždin, HRV, 42000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Finland1 site

  • Novartis Investigative Site

    Turku, 20520

Other trials in Finland

Iceland1 site

  • Novartis Investigative Site

    Reykjavik, IS-101

Other trials in Iceland

Latvia1 site

  • Novartis Investigative Site

    Daugavpils, LV-5417

Other trials in Latvia

About this study

Official title: A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

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).

Read the detailed description

This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).

Being tested
Serelaxin, Standard of Care
Keywords
AHF,, RLX030,, SOC,, WHF,, RELAX-AHF-EU, Renal Impairment
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SerelaxinDrug

    Also called RLX030

    30 µg/kg/day IV infusion

  • Standard of CareDrug

    This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Study groups in NCT02064868
Study groupRoleWhat they receive
Serelaxin + Standard of CareExperimentalSerelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
Receives: Drug: Serelaxin; Drug: Standard of Care
Standard of Care (SOC)OtherAll patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 days

Secondary outcomes (6)

  1. 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.

    Measured: 14 days

  2. 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.

    Measured: 5 days

  3. 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.

    Measured: 14 days

  4. 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.

    Measured: 30 Days

  5. Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients

    Measured: Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days

  6. 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).

    Measured: Baseline, Day 5, Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study start31 Jan 2014
  3. Primary completion26 Mar 2017
  4. Study completion25 Apr 2017

Why it stopped: Study was terminated based on results from pivotal adult AHF study CRLX030A2301

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02064868
Sponsor's protocol ID
CRLX030A3301
Other IDs
2013-002513-35
Acronym
RELAX-AHF-EU
Status last verified
Dec 2018
First submitted
14 Feb 2014
Last updated
22 Mar 2019
Data monitoring committee
Yes

Publications

  • Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.

    PubMed 35184572

  • Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

    PubMed 34514815

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Serelaxin in people with Acute Heart Failure (AHF), run by Novartis Pharmaceuticals at 357 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 357 sites in Germany, France, Spain, Italy, Russia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02064868, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.

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