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

December 18, 2018 updated by: Novartis Pharmaceuticals

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2666

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, A-6807
        • Novartis Investigative Site
      • Graz, Austria, 8020
        • Novartis Investigative Site
      • Linz, Austria, A-4020
        • Novartis Investigative Site
      • Salzburg, Austria, A-5020
        • Novartis Investigative Site
      • Salzburg, Austria, 5010
        • Novartis Investigative Site
      • St. Poelten, Austria, 3100
        • Novartis Investigative Site
      • Vienna, Austria, 1130
        • Novartis Investigative Site
      • Vienna, Austria, A-1020
        • Novartis Investigative Site
      • Wien, Austria, A-1160
        • Novartis Investigative Site
  • Belgium
      • Aalst, Belgium, 9300
        • Novartis Investigative Site
      • Brugge, Belgium, 8000
        • Novartis Investigative Site
      • Brussel, Belgium, 1090
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Hasselt, Belgium, 3500
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
      • Lodelinsart, Belgium, 6042
        • Novartis Investigative Site
      • Mol, Belgium, 2400
        • Novartis Investigative Site
      • Mons, Belgium, 7000
        • Novartis Investigative Site
      • Roeselare, Belgium, 8800
        • Novartis Investigative Site
      • Ronse, Belgium, 9600
        • Novartis Investigative Site
      • Turnhout, Belgium, 2300
        • Novartis Investigative Site
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4000
        • Novartis Investigative Site
      • Ruse, Bulgaria, 7002
        • Novartis Investigative Site
      • Sliven, Bulgaria, 8800
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1233
        • Novartis Investigative Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Novartis Investigative Site
  • Croatia
      • Zagreb, Croatia, 10000
        • Novartis Investigative Site
    • HRV
      • Varazdin, HRV, Croatia, 42000
        • Novartis Investigative Site
  • Czechia
      • Plzen, Czechia, 301 00
        • Novartis Investigative Site
      • Prague 5, Czechia, 150 06
        • Novartis Investigative Site
    • Czech Republic
      • Brno, Czech Republic, Czechia, 656 91
        • Novartis Investigative Site
      • Decin II, Czech Republic, Czechia, 405 99
        • Novartis Investigative Site
      • Karvina-Raj, Czech Republic, Czechia, 73412
        • Novartis Investigative Site
      • Kromeriz, Czech Republic, Czechia, 767 55
        • Novartis Investigative Site
      • Melnik, Czech Republic, Czechia, 27601
        • Novartis Investigative Site
      • Pisek, Czech Republic, Czechia, 39701
        • Novartis Investigative Site
      • Svitavy, Czech Republic, Czechia, 568 25
        • Novartis Investigative Site
      • Tabor, Czech Republic, Czechia, 39003
        • Novartis Investigative Site
      • Trebic, Czech Republic, Czechia, 674 01
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Novartis Investigative Site
      • Tartu, Estonia, 51014
        • Novartis Investigative Site
  • Finland
      • Turku, Finland, 20520
        • Novartis Investigative Site
  • France
      • Abbeville, France, 80100
        • Novartis Investigative Site
      • Agen Cedex 9, France, 47923
        • Novartis Investigative Site
      • Amiens cedex 1, France, 80054
        • Novartis Investigative Site
      • Avignon, France, 84000
        • Novartis Investigative Site
      • Belfort, France, 90 016
        • Novartis Investigative Site
      • Besancon Cedex, France, 25030
        • Novartis Investigative Site
      • Brest, France, 29200
        • Novartis Investigative Site
      • Bron, France, 69677
        • Novartis Investigative Site
      • Chalon sur Saône, France, 71321
        • Novartis Investigative Site
      • Chambray-lès-Tours, France, 37170
        • Novartis Investigative Site
      • Chateauroux, France, 36000
        • Novartis Investigative Site
      • Clermont-Ferrand, France, 63003
        • Novartis Investigative Site
      • Corbeil Essonnes, France, 91100
        • Novartis Investigative Site
      • Dunkerque, France, 59385
        • Novartis Investigative Site
      • La Seyne sur mer, France, 83500
        • Novartis Investigative Site
      • Le Coudray, France, 28630
        • Novartis Investigative Site
      • Le Mans Cedex 09, France, 72037
        • Novartis Investigative Site
      • Lens, France, 62307
        • Novartis Investigative Site
      • Limoges Cedex, France, 87042
        • Novartis Investigative Site
      • Lorient Cedex, France, 56322
        • Novartis Investigative Site
      • Metz, France, 57085
        • Novartis Investigative Site
      • Montauban, France, 82013
        • Novartis Investigative Site
      • Montauban, France, 82017
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Novartis Investigative Site
      • Mulhouse cedex, France, 68070
        • Novartis Investigative Site
      • Nimes Cedex 09, France, 30029
        • Novartis Investigative Site
      • Niort, France, 79021
        • Novartis Investigative Site
      • Orleans, France, 45100
        • Novartis Investigative Site
      • Paris, France, 75013
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Paris cedex 10, France, 75010
        • Novartis Investigative Site
      • Pau, France, 64000
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Novartis Investigative Site
      • Périgueux, France, 24019
        • Novartis Investigative Site
      • Rennes Cedex 9, France, 35033
        • Novartis Investigative Site
      • Saint Brieuc, France, 22027
        • Novartis Investigative Site
      • St Michel, France, 16470
        • Novartis Investigative Site
      • St Priest en Jarez Cedex, France, 42277
        • Novartis Investigative Site
      • Strasbourg Cedex, France, 67091
        • Novartis Investigative Site
      • Troyes, France, 10003
        • Novartis Investigative Site
      • Vienne, France, 38209
        • Novartis Investigative Site
    • Bouches Du Rhone
      • Marseille cedex 20, Bouches Du Rhone, France, 13915
        • Novartis Investigative Site
    • Cedex
      • Nancy, Cedex, France, 54035
        • Novartis Investigative Site
  • Germany
      • Arnstadt, Germany, 99310
        • Novartis Investigative Site
      • Bad Berka, Germany, 99438
        • Novartis Investigative Site
      • Bad Oeynhausen, Germany, 32545
        • Novartis Investigative Site
      • Baden-Baden, Germany, 76532
        • Novartis Investigative Site
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Berlin, Germany, 12683
        • Novartis Investigative Site
      • Berlin, Germany, 13187
        • Novartis Investigative Site
      • Berlin, Germany, 10405
        • Novartis Investigative Site
      • Berlin, Germany, 12526
        • Novartis Investigative Site
      • Bernburg, Germany, 06406
        • Novartis Investigative Site
      • Bochum, Germany, 44791
        • Novartis Investigative Site
      • Buchholz in der Nordheide, Germany, 21244
        • Novartis Investigative Site
      • Chemnitz, Germany, 09117
        • Novartis Investigative Site
      • Chemnitz, Germany, 09113
        • Novartis Investigative Site
      • Dorsten, Germany, 46282
        • Novartis Investigative Site
      • Dortmund, Germany, 44379
        • Novartis Investigative Site
      • Dortmund, Germany, 44263
        • Novartis Investigative Site
      • Dortmund, Germany, 44309
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Duisburg, Germany, 47137
        • Novartis Investigative Site
      • Duisburg, Germany, 47228
        • Novartis Investigative Site
      • Düssledorf, Germany, 40217
        • Novartis Investigative Site
      • Erfurt, Germany, 99089
        • Novartis Investigative Site
      • Erfurt, Germany, 99097
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Eschwege, Germany, 37269
        • Novartis Investigative Site
      • Esslingen, Germany, 73730
        • Novartis Investigative Site
      • Frankfurt, Germany, 65929
        • Novartis Investigative Site
      • Frankfurt, Germany, 60316
        • Novartis Investigative Site
      • Friesoythe, Germany, 26169
        • Novartis Investigative Site
      • Gera, Germany, 07548
        • Novartis Investigative Site
      • Gotha, Germany, 99867
        • Novartis Investigative Site
      • Greifswald, Germany, 17475
        • Novartis Investigative Site
      • Guetersloh, Germany, 33332
        • Novartis Investigative Site
      • Hamburg, Germany, 22457
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Heidenheim, Germany, 89522
        • Novartis Investigative Site
      • Hennigsdorf, Germany, 16761
        • Novartis Investigative Site
      • Herford, Germany, 32049
        • Novartis Investigative Site
      • Hoyerswerda, Germany, 02977
        • Novartis Investigative Site
      • Kaufbeuren, Germany, 87600
        • Novartis Investigative Site
      • Koblenz, Germany, 56073
        • Novartis Investigative Site
      • Koeln-Nippes, Germany, 50733
        • Novartis Investigative Site
      • Langen, Germany, 63225
        • Novartis Investigative Site
      • Lemgo, Germany, 32657
        • Novartis Investigative Site
      • Leverkusen, Germany, 51379
        • Novartis Investigative Site
      • Lüneburg, Germany, 21339
        • Novartis Investigative Site
      • Mannheim, Germany, 68167
        • Novartis Investigative Site
      • Marburg, Germany, 35039
        • Novartis Investigative Site
      • Marl, Germany, 45768
        • Novartis Investigative Site
      • Memmingen, Germany, 87700
        • Novartis Investigative Site
      • Moenchengladbach, Germany, 41063
        • Novartis Investigative Site
      • Muelheim, Germany, 45468
        • Novartis Investigative Site
      • Muenchen, Germany, 81379
        • Novartis Investigative Site
      • Neumünster, Germany, 24534
        • Novartis Investigative Site
      • Neunkirchen, Germany, 66538
        • Novartis Investigative Site
      • Neuss, Germany, 41464
        • Novartis Investigative Site
      • Neustadt A.d. Aisch, Germany, 91413
        • Novartis Investigative Site
      • Neuwied, Germany, 56564
        • Novartis Investigative Site
      • Nürnberg, Germany, 90419
        • Novartis Investigative Site
      • Ribnitz-Damgarten, Germany, 18311
        • Novartis Investigative Site
      • Rostock, Germany, 18057
        • Novartis Investigative Site
      • Rotenburg, Germany, 27356
        • Novartis Investigative Site
      • Schoenebeck, Germany, 39218
        • Novartis Investigative Site
      • Schwabach, Germany, 91126
        • Novartis Investigative Site
      • Schwalmstadt, Germany, 34613
        • Novartis Investigative Site
      • Singen, Germany, 78224
        • Novartis Investigative Site
      • Soest, Germany, 59494
        • Novartis Investigative Site
      • Sonneberg, Germany, 96515
        • Novartis Investigative Site
      • Speyer, Germany, 67346
        • Novartis Investigative Site
      • Stade, Germany, 21682
        • Novartis Investigative Site
      • Stadtlohn, Germany, 48703
        • Novartis Investigative Site
      • Stuttgart, Germany, 70376
        • Novartis Investigative Site
      • Suhl, Germany, 98527
        • Novartis Investigative Site
      • Torgau, Germany, 04860
        • Novartis Investigative Site
      • Trier, Germany, 54292
        • Novartis Investigative Site
      • Tuebingen, Germany, 72076
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Novartis Investigative Site
      • Vechta, Germany, 49377
        • Novartis Investigative Site
      • Wesel, Germany, 46483
        • Novartis Investigative Site
      • Witten, Germany, 58455
        • Novartis Investigative Site
      • Worms, Germany, 67550
        • Novartis Investigative Site
      • Wuerzburg, Germany, 97078
        • Novartis Investigative Site
      • Wuppertal, Germany, 42109
        • Novartis Investigative Site
      • Wurzen, Germany, 04808
        • Novartis Investigative Site
    • Schleswig Holstein
      • Flensburg, Schleswig Holstein, Germany, 24939
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Novartis Investigative Site
      • Athens, Greece, 115 28
        • Novartis Investigative Site
      • Athens, Greece, 115 21
        • Novartis Investigative Site
      • Volos, Greece, GR 38222
        • Novartis Investigative Site
    • Evros
      • Alexandroupolis, Evros, Greece, 681 00
        • Novartis Investigative Site
    • GR
      • Voula, GR, Greece, 166 73
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H 1096
        • Novartis Investigative Site
      • Budapest, Hungary, H-1032
        • Novartis Investigative Site
      • Budapest, Hungary, 1096
        • Novartis Investigative Site
      • Budapest, Hungary, H-1115
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Eger, Hungary, H-3300
        • Novartis Investigative Site
      • Gyor, Hungary, H-9023
        • Novartis Investigative Site
      • Kalocsa, Hungary, 6300
        • Novartis Investigative Site
      • Kecskemet, Hungary, 6000
        • Novartis Investigative Site
      • Kistarcsa, Hungary, 2143
        • Novartis Investigative Site
      • Mako, Hungary, 6900
        • Novartis Investigative Site
      • Szeged, Hungary, H-6725
        • Novartis Investigative Site
      • Szolnok, Hungary, 5004
        • Novartis Investigative Site
  • Iceland
      • Reykjavik, Iceland, IS-101
        • Novartis Investigative Site
  • Italy
      • Pozzuoli, Italy, 80078
        • Novartis Investigative Site
    • AP
      • San Benedetto del Tronto, AP, Italy, 63039
        • Novartis Investigative Site
    • AR
      • Arezzo, AR, Italy, 52100
        • Novartis Investigative Site
    • BA
      • Acquaviva delle Fonti, BA, Italy, 70021
        • Novartis Investigative Site
      • Altamura, BA, Italy, 70022
        • Novartis Investigative Site
      • Cassano delle Murge, BA, Italy, 70020
        • Novartis Investigative Site
    • BG
      • Treviglio, BG, Italy, 24047
        • Novartis Investigative Site
    • CA
      • Cagliari, CA, Italy, 09134
        • Novartis Investigative Site
    • CT
      • Catania, CT, Italy, 95100
        • Novartis Investigative Site
    • LO
      • Lodi, LO, Italy, 26900
        • Novartis Investigative Site
    • LT
      • Latina, LT, Italy, 04100
        • Novartis Investigative Site
    • ME
      • Messina, ME, Italy, 98125
        • Novartis Investigative Site
    • MI
      • Cernusco sul Naviglio, MI, Italy, 20063
        • Novartis Investigative Site
      • Legnano, MI, Italy, 20025
        • Novartis Investigative Site
    • Mount
      • Matera, Mount, Italy, 75100
        • Novartis Investigative Site
    • PC
      • Piacenza, PC, Italy, 29100
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italy, 33170
        • Novartis Investigative Site
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Novartis Investigative Site
      • Scandiano, RE, Italy, 42019
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00152
        • Novartis Investigative Site
      • Roma, RM, Italy, 00189
        • Novartis Investigative Site
      • Roma, RM, Italy, 00135
        • Novartis Investigative Site
      • Roma, RM, Italy, 00177
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
    • SR
      • Siracusa, SR, Italy, 96100
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italy, 07100
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italy, 10043
        • Novartis Investigative Site
      • Torino, TO, Italy, 10153
        • Novartis Investigative Site
      • Torino, TO, Italy, 10154
        • Novartis Investigative Site
    • VA
      • Busto Arsizio, VA, Italy, 21052
        • Novartis Investigative Site
    • VE
      • Chioggia, VE, Italy, 30015
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Italy, 36100
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37134
        • Novartis Investigative Site
    • VV
      • Vibo Valentia, VV, Italy, 89900
        • Novartis Investigative Site
  • Latvia
      • Daugavpils, Latvia, LV-5417
        • Novartis Investigative Site
  • Lithuania
      • Klaipeda, Lithuania, 92288
        • Novartis Investigative Site
      • Vilnius, Lithuania, LT-08661
        • Novartis Investigative Site
    • LT
      • Kaunas, LT, Lithuania, LT-45130
        • Novartis Investigative Site
    • LTU
      • Kaunas, LTU, Lithuania, LT-50161
        • Novartis Investigative Site
  • Poland
      • Bilgoraj, Poland, 23-400
        • Novartis Investigative Site
      • Gdansk, Poland, 80 952
        • Novartis Investigative Site
      • Grodzisk Mazowiecki, Poland, 05-825
        • Novartis Investigative Site
      • Kielce, Poland, 25-317
        • Novartis Investigative Site
      • Krakow, Poland, 31 501
        • Novartis Investigative Site
      • Krakow, Poland, 30-901
        • Novartis Investigative Site
      • Lubin, Poland, 59-301
        • Novartis Investigative Site
      • Lublin, Poland, 20-718
        • Novartis Investigative Site
      • Oswiecim, Poland, 32-600
        • Novartis Investigative Site
      • Rzeszow, Poland, 35-241
        • Novartis Investigative Site
      • Tarnobrzeg, Poland, 39-400
        • Novartis Investigative Site
      • Tarnow, Poland, 33-100
        • Novartis Investigative Site
      • Walbrzych, Poland, 58-309
        • Novartis Investigative Site
    • POL
      • Krakow, POL, Poland, 31-121
        • Novartis Investigative Site
  • Portugal
      • Almada, Portugal, 2801 951
        • Novartis Investigative Site
      • Barreiro, Portugal, 2834-003
        • Novartis Investigative Site
      • Braga, Portugal, 4710243
        • Novartis Investigative Site
      • Lisboa, Portugal, 1500 650
        • Novartis Investigative Site
      • Lisboa, Portugal, 1495-005
        • Novartis Investigative Site
      • Matosinhos, Portugal, 4454-509
        • Novartis Investigative Site
      • Setubal, Portugal, 2910-446
        • Novartis Investigative Site
      • Vila Franca de Xira, Portugal, 2600-009
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 022322
        • Novartis Investigative Site
      • Sibiu, Romania, 550245
        • Novartis Investigative Site
      • Tirgoviste, Romania, 130095
        • Novartis Investigative Site
    • District 4
      • Bucuresti, District 4, Romania, 4204179
        • Novartis Investigative Site
    • Jud Cluj
      • Bucharest, Jud Cluj, Romania, 010825
        • Novartis Investigative Site
    • Jud. Iasi
      • Craiova, Jud. Iasi, Romania, 200642
        • Novartis Investigative Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454092
        • Novartis Investigative Site
      • Chelyabinsk, Russian Federation, 454000
        • Novartis Investigative Site
      • Chita, Russian Federation, 672039
        • Novartis Investigative Site
      • Gatchina, Russian Federation, 188300
        • Novartis Investigative Site
      • Izhevsk, Russian Federation, 426009
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420012
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420103
        • Novartis Investigative Site
      • Kirov, Russian Federation, 610027
        • Novartis Investigative Site
      • Krasnoyarsk, Russian Federation, 660022
        • Novartis Investigative Site
      • Moscow, Russian Federation, 121359
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127473
        • Novartis Investigative Site
      • Moscow, Russian Federation, 117997
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115280
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127994
        • Novartis Investigative Site
      • Novosibirsk, Russian Federation, 630003
        • Novartis Investigative Site
      • Penza, Russian Federation, 440026
        • Novartis Investigative Site
      • Petrozavodsk, Russian Federation, 185031
        • Novartis Investigative Site
      • Rostov-on-Don, Russian Federation, 344068
        • Novartis Investigative Site
      • Ryazan, Russian Federation, 390026
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 194044
        • Novartis Investigative Site
      • Saratov, Russian Federation, 410028
        • Novartis Investigative Site
      • St.-Petersburg, Russian Federation, 194044
        • Novartis Investigative Site
      • Tyumen, Russian Federation, 625023
        • Novartis Investigative Site
      • Ufa, Russian Federation, 450071
        • Novartis Investigative Site
      • Vladivostok, Russian Federation, 690002
        • Novartis Investigative Site
      • Volgograd, Russian Federation, 400008
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150047
        • Novartis Investigative Site
      • Zelenograd, Moscow Region, Russian Federation, 124489
        • Novartis Investigative Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novartis Investigative Site
      • Belgrade, Serbia, 11 000
        • Novartis Investigative Site
      • Belgrade, Serbia, 11080
        • Novartis Investigative Site
      • Kamenica, Serbia, 21204
        • Novartis Investigative Site
      • Nis, Serbia, 18000
        • Novartis Investigative Site
      • Niska Banja, Serbia, 18205
        • Novartis Investigative Site
  • Slovakia
      • Brezno, Slovakia, 97701
        • Novartis Investigative Site
      • Poprad, Slovakia, 05845
        • Novartis Investigative Site
      • Trencin, Slovakia, 91171
        • Novartis Investigative Site
    • Slovak Republic
      • Dunajska Streda, Slovak Republic, Slovakia, 92901
        • Novartis Investigative Site
      • Skalica, Slovak Republic, Slovakia, 909 82
        • Novartis Investigative Site
      • Zvolen, Slovak Republic, Slovakia, 96001
        • Novartis Investigative Site
  • Slovenia
      • Celje, Slovenia, 3000
        • Novartis Investigative Site
      • Jesenice, Slovenia, 4270
        • Novartis Investigative Site
      • Ljubljana, Slovenia, 1000
        • Novartis Investigative Site
      • Murska Sobota, Slovenia, 9000
        • Novartis Investigative Site
  • Spain
      • Leon, Spain, 24080
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Murcia, Spain, 30003
        • Novartis Investigative Site
      • Zaragoza, Spain, 50009
        • Novartis Investigative Site
    • Andalucia
      • Granada, Andalucia, Spain, 18014
        • Novartis Investigative Site
      • Granada, Andalucia, Spain, 18012
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
      • Sanlucar de Barrameda, Andalucia, Spain, 11540
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41013
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41014
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Novartis Investigative Site
    • Cadiz
      • Villamartin, Cadiz, Spain, 11650
        • Novartis Investigative Site
    • Castilla La Mancha
      • Toledo, Castilla La Mancha, Spain, 45071
        • Novartis Investigative Site
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Spain, 37007
        • Novartis Investigative Site
      • Soria, Castilla Y Leon, Spain, 42005
        • Novartis Investigative Site
    • Cataluna
      • Lleida, Cataluna, Spain, 25198
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
      • Terrassa, Catalunya, Spain, 08227
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Novartis Investigative Site
      • Alicante, Comunidad Valenciana, Spain, 03550
        • Novartis Investigative Site
      • Alzira, Comunidad Valenciana, Spain, 46600
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46014
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46015
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46017
        • Novartis Investigative Site
    • Extremadura
      • Caceres, Extremadura, Spain, 10003
        • Novartis Investigative Site
    • Galicia
      • La Coruna, Galicia, Spain, 15006
        • Novartis Investigative Site
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
    • Las Palmas De G.C
      • Las Palmas de Gran Canaria, Las Palmas De G.C, Spain, 35010
        • Novartis Investigative Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Novartis Investigative Site
      • Fuenlabrada, Madrid, Spain, 28942
        • Novartis Investigative Site
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Novartis Investigative Site
      • El Palmar, Murcia, Spain, 30120
        • Novartis Investigative Site
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48013
        • Novartis Investigative Site
      • Galdakano, Pais Vasco, Spain, 48960
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Novartis Investigative Site
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
      • Geneve 14, Switzerland, 1211
        • Novartis Investigative Site
      • Liestal, Switzerland, 4410
        • Novartis Investigative Site
      • Lugano, Switzerland, 6903
        • Novartis Investigative Site
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Novartis Investigative Site
      • Cardiff, United Kingdom, CF14 4XW
        • Novartis Investigative Site
      • Dundee, United Kingdom, DD1 9SY
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L9 7AL
        • Novartis Investigative Site
      • London, United Kingdom, SW17 ORE
        • Novartis Investigative Site
      • Swindon, United Kingdom, SN3 6BB
        • Novartis Investigative Site
    • County Durham
      • Durham, County Durham, United Kingdom, DH1 5TW
        • Novartis Investigative Site
    • Dorset
      • Dorchester, Dorset, United Kingdom, DT1 2JY
        • Novartis Investigative Site
    • GBR
      • Peterborough, GBR, United Kingdom, PE3 6DA
        • Novartis Investigative Site
    • Tyne And Wear
      • Gateshead, Tyne And Wear, United Kingdom, NE9 6SX
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Serelaxin + Standard of Care
Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
Drug: Serelaxin
30 µg/kg/day IV infusion
Other Names:
  • RLX030
Drug: Standard of Care
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.
Other: Standard of Care (SOC)
All 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.
Drug: Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5
Time Frame: 5 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14
Time Frame: 14 days
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
Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5
Time Frame: 5 days
Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.
5 days
Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14
Time Frame: 14 days
Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine.
14 days
Length of Index Hospital Stay
Time Frame: 30 Days
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
Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients
Time Frame: Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days
Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days
Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.
Time Frame: Baseline, Day 5, Day 14
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRLX030A3301
  • 2013-002513-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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