AzTrials
AzTrials

Acute Heart FailurePhase 3RELAX-AHF-2NCT01870778

Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF

A Phase 3 study testing RLX030 in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 540 sites in 35 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure
What is being tested?
RLX030
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,600 participants
Where
540 sitesin 35 countries
Study dates
2 Oct 2013to 1 Feb 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

  • Male or female 18 years of age, with body weight ≤160 kg
  • Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department) and the end of screening:
  • Persistent dyspnea at rest or with minimal exertion
  • Pulmonary congestion on chest radiograph
  • B-type natriuretic peptide (BNP) ≥500 pg/mL or N-terminal (NT)-proBNP ≥2000 pg/mL; for patients ≥ 75 years of age or with current atrial fibrillation (at the time of randomization), BNP ≥ 750 pg/mL or NT-proBNP ≥ 3,000 pg/mL
  • Systolic BP ≥125 mmHg at the start and at the end of screening
  • Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
  • Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode.

Who cannot join

  • Dyspnea primarily due to non-cardiac causes
  • Known history of respiratory disorders requiring the daily use of IV or oral steroids (does not include inhaled steroids); need for intubation or the current use of IV or oral steroids for chronic obstructive pulmonary disease (COPD)
  • Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
  • Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
  • AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
  • Patients with severe renal impairment defined as pre-randomization estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m2 calculated using the Simplified Modification of Diet in Renal Disease (sMDRD) equation, and/or those receiving current or planned dialysis or ultrafiltration
Show all 11Show fewer
  • Patients with hematocrit <25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding.
  • Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased ammonia levels, if performed) or history of cirrhosis with evidence of portal hypertension such as varices.
  • Significant, uncorrected, left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >40 mmHg on prior or current echocardiogram), and severe mitral stenosis
  • Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.
  • Documented, prior to or at the time of randomization, restrictive amyloid myocardiopathy, OR 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

540 sites in 35 countries.

540 sites in 35 countries

United States105 sites

  • Novartis Investigative Site

    Abington, Pennsylvania, 19001

  • Novartis Investigative Site

    Alexandria, Louisiana, 71301

  • Novartis Investigative Site

    Anaheim, California, 92801

  • Novartis Investigative Site

    Annapolis, Maryland, 21401

  • Novartis Investigative Site

    Atlanta, Georgia, 30310

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

  • Novartis Investigative Site

    Atlantis, Florida, 33462

  • Novartis Investigative Site

    Baltimore, Maryland, 21201

  • Novartis Investigative Site

    Baltimore, Maryland, 21287

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70808

  • Novartis Investigative Site

    Boston, Massachusetts, 02114

  • Novartis Investigative Site

    Boston, Massachusetts, 02115

  • Novartis Investigative Site

    Boston, Massachusetts

  • Novartis Investigative Site

    Brooklyn, New York, 11203

  • Novartis Investigative Site

    Brooklyn, New York, 11215

  • Novartis Investigative Site

    Canton, Ohio, 44710

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599-7075

  • Novartis Investigative Site

    Charlottesville, Virginia, 22908

  • Novartis Investigative Site

    Chicago, Illinois, 60637

  • Novartis Investigative Site

    Cincinnati, Ohio, 45220

  • Novartis Investigative Site

    Cincinnati, Ohio, 45267-0585

  • Novartis Investigative Site

    Cleveland, Ohio, 44195

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80909

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • Novartis Investigative Site

    Covington, Louisiana, 70433

  • Novartis Investigative Site

    Dallas, Texas, 75216

  • Novartis Investigative Site

    Dallas, Texas, 75226

  • Novartis Investigative Site

    Denver, Colorado, 80204-4507

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Detroit, Michigan, 48202

  • Novartis Investigative Site

    Detroit, Michigan, 48235

  • Novartis Investigative Site

    Durham, North Carolina, 27710

  • Novartis Investigative Site

    Elk Grove Village, Illinois, 60007

  • Novartis Investigative Site

    Falls Church, Virginia, 22042

  • Novartis Investigative Site

    Fresno, California, 93720

  • Novartis Investigative Site

    Galveston, Texas, 77555

  • Novartis Investigative Site

    Greenville, South Carolina, 29607

  • Novartis Investigative Site

    Greenville, South Carolina, 29615

  • Novartis Investigative Site

    Hartford, Connecticut, 06102

  • Novartis Investigative Site

    Hartford, Connecticut, 06105

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Huntsville, Alabama, 35801

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202-5111

  • Novartis Investigative Site

    Indianapolis, Indiana, 46237

  • Novartis Investigative Site

    Jackson, Mississippi, 39216

  • Novartis Investigative Site

    Jacksonville, Florida, 32207

  • Novartis Investigative Site

    Jacksonville, Florida, 32209

  • Novartis Investigative Site

    Jacksonville, Florida, 32216

  • Novartis Investigative Site

    Kansas City, Kansas, 66160

  • Novartis Investigative Site

    Kansas City, Missouri, 64108

  • Novartis Investigative Site

    Kingston, New York, 12401

  • Novartis Investigative Site

    Loma Linda, California, 92354

  • Novartis Investigative Site

    Los Angeles, California, 90033

  • Novartis Investigative Site

    Los Angeles, California, 90073

  • Novartis Investigative Site

    Los Angeles, California, 90095

  • Novartis Investigative Site

    Lynchburg, Virginia, 24501

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55417

  • Novartis Investigative Site

    Montgomery, Alabama, 36106

  • Novartis Investigative Site

    Morgantown, West Virginia, 26506

  • Novartis Investigative Site

    Muncie, Indiana, 47303-3400

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    Nashville, Tennessee, 37212

  • Novartis Investigative Site

    Natrona Heights, Pennsylvania, 15065

  • Novartis Investigative Site

    New Hyde Park, New York, 11040

  • Novartis Investigative Site

    New Orleans, Louisiana, 70112

  • Novartis Investigative Site

    Northridge, California, 91325

  • Novartis Investigative Site

    Oakbrook Terrace, Illinois, 60181

  • Novartis Investigative Site

    Omaha, Nebraska, 68198

  • Novartis Investigative Site

    Palo Alto, California, 94304-1207

  • Novartis Investigative Site

    Peoria, Illinois, 61602

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19102 2293

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19107

  • Novartis Investigative Site

    Picayune, Mississippi, 39466

  • Novartis Investigative Site

    Portland, Oregon, 97219

  • Novartis Investigative Site

    Providence, Rhode Island, 02903

  • Novartis Investigative Site

    Raleigh, North Carolina, 27610

  • Novartis Investigative Site

    Roanoke, Virginia, 24014

  • Novartis Investigative Site

    Rochester, New York, 14642

  • Novartis Investigative Site

    Sacramento, California, 95817-1460

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Antonio, Texas, 78234

  • Novartis Investigative Site

    San Diego, California, 92103

  • Novartis Investigative Site

    San Diego, California, 92123

  • Novartis Investigative Site

    San Diego, California, 92161

  • Novartis Investigative Site

    Sanford, Florida, 32771

  • Novartis Investigative Site

    Sarasota, Florida, 34239

  • Novartis Investigative Site

    Seattle, Washington, 98101

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    St Louis, Missouri, 63128

  • Novartis Investigative Site

    St Louis, Missouri, 63136

  • Novartis Investigative Site

    Stony Brook, New York, 11794

  • Novartis Investigative Site

    Sylmar, California, 91342

  • Novartis Investigative Site

    Tampa, Florida, 33606

  • Novartis Investigative Site

    Tampa, Florida, 33612

  • Novartis Investigative Site

    The Bronx, New York, 10461

  • Novartis Investigative Site

    The Bronx, New York, 10467-2490

  • Novartis Investigative Site

    Toledo, Ohio, 43614

  • Novartis Investigative Site

    Tucson, Arizona, 85723-0001

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    Warwick, Rhode Island, 02886

  • Novartis Investigative Site

    Winter Haven, Florida, 33881

  • Novartis Investigative Site

    Worcester, Massachusetts, 01655

  • Novartis Investigative Site

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Germany65 sites

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 12621

  • Novartis Investigative Site

    Berlin, 13347

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 13509

  • Novartis Investigative Site

    Berlin, 13578

  • Novartis Investigative Site

    Bitburg, 54634

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Bonn, 53115

  • Novartis Investigative Site

    Brandenburg, 16321

  • Novartis Investigative Site

    Bremen, 28277

  • Novartis Investigative Site

    Coburg, 96450

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Detmold, 32756

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Dortmund, 44379

  • Novartis Investigative Site

    Dresden, 01067

  • Novartis Investigative Site

    Erfurt, 99084

  • Novartis Investigative Site

    Erfurt, 99089

  • Novartis Investigative Site

    Essen, 45122

  • Novartis Investigative Site

    Essen, 45356

  • Novartis Investigative Site

    Frankfurt, 60488

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Frankfurt, 65929

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Friedberg, 86316

  • Novartis Investigative Site

    Füssen, 87629

  • Novartis Investigative Site

    Göttingen, 37073

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hamburg, 22291

  • Novartis Investigative Site

    Heilbronn, 74078

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Kleve, 47533

  • Novartis Investigative Site

    Koeln-Nippes, 50733

  • Novartis Investigative Site

    Langen, 63225

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leverkusen, 51375

  • Novartis Investigative Site

    Limburg, 65549

  • Novartis Investigative Site

    Lübeck, 23569

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Magdeburg, 39104

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Merseburg, 06217

  • Novartis Investigative Site

    Mönchengladbach, 41063

  • Novartis Investigative Site

    München, 80636

  • Novartis Investigative Site

    Neuwied, 56564

  • Novartis Investigative Site

    Oldenburg, 26133

  • Novartis Investigative Site

    Regensburg, 93053

  • Novartis Investigative Site

    Rüsselsheim am Main, 65428

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Villingen-Schwenningen, 78052

  • Novartis Investigative Site

    Weiden, 92637

  • Novartis Investigative Site

    Witten, 58455

  • Novartis Investigative Site

    Wuppertal, 42117

  • Novartis Investigative Site

    Würzburg, 97078

  • Novartis Investigative Site

    Zwickau, 08060

Other trials in Germany

Argentina34 sites

  • Novartis Investigative Site

    Buenos Aires, B1602ABQ

  • Novartis Investigative Site

    Buenos Aires, B1846BMF

  • Novartis Investigative Site

    Buenos Aires, C1039AAP

  • Novartis Investigative Site

    Buenos Aires, C1120AAF

  • Novartis Investigative Site

    Buenos Aires, C1405CNF

  • Novartis Investigative Site

    Buenos Aires, C1425AGP

  • Novartis Investigative Site

    Buenos Aires, C1428DCO

  • Novartis Investigative Site

    Buenos Aires, W3400ABH

  • Novartis Investigative Site

    Caba, Buenos Aires, C1280AEB

  • Novartis Investigative Site

    CABA, Buenos Aires, C1180AAX

  • Novartis Investigative Site

    Carapachay, Buenos Aires, B1605

  • Novartis Investigative Site

    Córdoba, X5000AAX

  • Novartis Investigative Site

    Córdoba, X5000EPU

  • Novartis Investigative Site

    Córdoba, X5004BAL

  • Novartis Investigative Site

    Córdoba, X5004CDT

  • Novartis Investigative Site

    Córdoba, X5006IKK

  • Novartis Investigative Site

    Córdoba, X5009BSN

  • Novartis Investigative Site

    Córdoba, X5016KET

  • Novartis Investigative Site

    Coronel Suárez, Buenos Aires, B7540GHD

  • Novartis Investigative Site

    Corrientes, W3400CBI

  • Novartis Investigative Site

    Corrientes, W3400

  • Novartis Investigative Site

    Formosa, P3600

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT

  • Novartis Investigative Site

    Rosario, Santa Fe Province, C2000DSR

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSV

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2001ODA

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2001SBL

  • Novartis Investigative Site

    Salta, A4400

  • Novartis Investigative Site

    San Martín, Buenos Aires, B1650CSQ

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000JCU

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000NIJ

  • Novartis Investigative Site

    San Salvador de Jujuy, Jujuy Province, Y4600ABF

  • Novartis Investigative Site

    Santa Fe, S3000EOZ

  • Novartis Investigative Site

    Santa Fe, S3000FUJ

Other trials in Argentina

Russia27 sites

  • Novartis Investigative Site

    Barnaul, 656038

  • Novartis Investigative Site

    Ivanovo, 153012

  • Novartis Investigative Site

    Kemerovo, 650002

  • Novartis Investigative Site

    Kemerovo, 650014

  • Novartis Investigative Site

    Kirov, 610014

  • Novartis Investigative Site

    Moscow, 111539

  • Novartis Investigative Site

    Moscow, 117292

  • Novartis Investigative Site

    Moscow, 121309

  • Novartis Investigative Site

    Moscow, 121552

  • Novartis Investigative Site

    Moscow, 127476

  • Novartis Investigative Site

    Moscow, 127644

  • Novartis Investigative Site

    Novosibirsk, 630008

  • Novartis Investigative Site

    S.-Petersburg, 192242

  • Novartis Investigative Site

    S.-Petersburg, 196247

  • Novartis Investigative Site

    S.-Petersburg, 198205

  • Novartis Investigative Site

    Saint Petersburg, 190013

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saint Petersburg, 195067

  • Novartis Investigative Site

    Saint Petersburg, 196601

  • Novartis Investigative Site

    Saint Petersburg, 199106

  • Novartis Investigative Site

    Samara, 443070

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Tomsk, 634012

  • Novartis Investigative Site

    Vladimir, 600020

  • Novartis Investigative Site

    Voronezh, 394065

  • Novartis Investigative Site

    Yaroslavl, 150030

  • Novartis Investigative Site

    Yekaterinburg, 620028

Other trials in Russia

Italy26 sites

  • Novartis Investigative Site

    Albano Laziale, RM, 00041

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Bolzano, BZ, 39100

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Cortona, AR, 52044

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Gavardo, BS, 25085

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Novara, 28100

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Pozzilli, IS, 86077

  • Novartis Investigative Site

    Rimini, RN, 47900

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Trieste, TS, 34149

  • Novartis Investigative Site

    Udine, UD, 33100

  • Novartis Investigative Site

    Vimercate, MI, 200059

Other trials in Italy

Spain22 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Getafe, Madrid, 28905

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    León, Castille and León, 24071

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Marbella, Andalusia, 29600

  • Novartis Investigative Site

    Sanlúcar de Barrameda, Andalusia, 11540

  • Novartis Investigative Site

    Sant Joan Despí, Barcelona, 08970

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46026

  • Novartis Investigative Site

    Villamartín, Cadiz, 11650

Other trials in Spain

France21 sites

  • Novartis Investigative Site

    Amiens, 80054

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Béziers, 34525

  • Novartis Investigative Site

    Bobigny, 93009

  • Novartis Investigative Site

    Caen, 14000

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170

  • Novartis Investigative Site

    La Tronche, 38700

  • Novartis Investigative Site

    Le Chesnay, 78157

  • Novartis Investigative Site

    Le Chesnay

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Lille, 59042

  • Novartis Investigative Site

    Nancy, 54035

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Paris, 75877

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Pontoise, F-95300

  • Novartis Investigative Site

    Rouen, 76000

  • Novartis Investigative Site

    Saint Herblain - Nantes, 44093

  • Novartis Investigative Site

    Toulouse, 31054

  • Novartis Investigative Site

    Tourcoing, 59208

Other trials in France

Romania19 sites

  • Novartis Investigative Site

    Arad, 310158

  • Novartis Investigative Site

    Baia Mare, 430031

  • Novartis Investigative Site

    Brăila, 810249

  • Novartis Investigative Site

    Brasov, 300 326

  • Novartis Investigative Site

    Bucharest, 014461

  • Novartis Investigative Site

    Bucharest, 020125

  • Novartis Investigative Site

    Bucharest, 021659

  • Novartis Investigative Site

    Bucharest, 022328

  • Novartis Investigative Site

    Bucharest, 041915

  • Novartis Investigative Site

    Bucharest, 050659

  • Novartis Investigative Site

    Craiova, 200642

  • Novartis Investigative Site

    Oradea, 410169

  • Novartis Investigative Site

    Piteşti, 110084

  • Novartis Investigative Site

    Târgu Mureş, Mureș County, 540136

  • Novartis Investigative Site

    Tg. Mures, Mureș County, 540136

  • Novartis Investigative Site

    Timișoara, 300 079

  • Novartis Investigative Site

    Timișoara, 300041

  • Novartis Investigative Site

    Timișoara, 300310

  • Novartis Investigative Site

    Timișoara, 300736

Other trials in Romania

Czechia18 sites

  • Novartis Investigative Site

    Benešov, 25601

  • Novartis Investigative Site

    Brno, 636 00

  • Novartis Investigative Site

    Brno-Bohunice, Czech Republic, 625 00

  • Novartis Investigative Site

    Frýdek-Místek, Czech Republic, 73801

  • Novartis Investigative Site

    Hradec Králové, CZE, 500 05

  • Novartis Investigative Site

    Jihlava, 586 01

  • Novartis Investigative Site

    Kladno, Czech Republic, 272 00

  • Novartis Investigative Site

    Kolín, 280 20

  • Novartis Investigative Site

    Liberec, Czech Republic, 46063

  • Novartis Investigative Site

    Pardubice, Czech Republic, 532 03

  • Novartis Investigative Site

    Pilsen, 301 00

  • Novartis Investigative Site

    Prague, Czech Republic, 169 02

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 12808

  • Novartis Investigative Site

    Slaný, Czech Republic, 27401

  • Novartis Investigative Site

    Ústí nad Labem, Czech Republic, 400 11

  • Novartis Investigative Site

    Ústí nad Orlicí, Czech Republic, 562 18

  • Novartis Investigative Site

    Zlín, Czech Republic, 76275

Other trials in Czechia

United Kingdom18 sites

  • Novartis Investigative Site

    Basingstoke, Hampshire, RG24 9NA

  • Novartis Investigative Site

    Blackburn, Lancashire, BB2 3HH

  • Novartis Investigative Site

    Blackpool, FY3 8NR

  • Novartis Investigative Site

    Dudley, West Midlands, DY1 2HQ

  • Novartis Investigative Site

    Edinburgh, EH16 4SA

  • Novartis Investigative Site

    Glasgow, G51 4TF

  • Novartis Investigative Site

    Hardwick, Stockton On Tees, TS19 8PE

  • Novartis Investigative Site

    High Wycombe, Buckinghamshire, HP11 2TT

  • Novartis Investigative Site

    Kettering, NN16 8UZ

  • Novartis Investigative Site

    Leicester, LE3 9QP

  • Novartis Investigative Site

    Liverpool, L7 8XP

  • Novartis Investigative Site

    Liverpool, L9 7AL

  • Novartis Investigative Site

    London, SE5 9RS

  • Novartis Investigative Site

    Manchester, M13 9WL

  • Novartis Investigative Site

    Nottingham, Hampshire, NG7 2UH

  • Novartis Investigative Site

    Portsmouth, PO6 3LY

  • Novartis Investigative Site

    Swindon, SN3 6BB

  • Novartis Investigative Site

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Hungary17 sites

  • Novartis Investigative Site

    Balatonfüred, H-8231

  • Novartis Investigative Site

    Budapest, 1027

  • Novartis Investigative Site

    Budapest, 1043

  • Novartis Investigative Site

    Budapest, 1085

  • Novartis Investigative Site

    Budapest, 1106

  • Novartis Investigative Site

    Budapest, 1125

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Budapest, 1145

  • Novartis Investigative Site

    Budapest, H 1096

  • Novartis Investigative Site

    Cegléd, 2700

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Mátészalka, 4700

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Székesfehérvár, H-8000

  • Novartis Investigative Site

    Szombathely, 9700

  • Novartis Investigative Site

    Zalaegerszeg, 8900

Other trials in Hungary

Poland16 sites

  • Novartis Investigative Site

    Bialystok, 15-276

  • Novartis Investigative Site

    Grodzisk Mazowiecki, 05-825

  • Novartis Investigative Site

    Kłodzko, 57-300

  • Novartis Investigative Site

    Krakow, POL, 31-121

  • Novartis Investigative Site

    Krakow, 31 501

  • Novartis Investigative Site

    Krakow, 31-202

  • Novartis Investigative Site

    Krakow, 31202

  • Novartis Investigative Site

    Lodz, 91-425

  • Novartis Investigative Site

    Lódz, 91-347

  • Novartis Investigative Site

    Oława, 55-200

  • Novartis Investigative Site

    Puławy, 24100

  • Novartis Investigative Site

    Warsaw, 01-211

  • Novartis Investigative Site

    Warsaw, 02-097

  • Novartis Investigative Site

    Warsaw, 04-628

  • Novartis Investigative Site

    Włocławek, 87-800

  • Novartis Investigative Site

    Wroclaw, 50-981

Other trials in Poland

Netherlands15 sites

  • Novartis Investigative Site

    Almelo, 7609 PP

  • Novartis Investigative Site

    Amersfoort, 3813 TZ

  • Novartis Investigative Site

    Amsterdam, 1105 AZ

  • Novartis Investigative Site

    Arnhem, 6815 AD

  • Novartis Investigative Site

    Deventer, 7416 SE

  • Novartis Investigative Site

    Gorinchem, 4204 AA

  • Novartis Investigative Site

    Groningen

  • Novartis Investigative Site

    Haarlem, 2035 RC

  • Novartis Investigative Site

    Hardenberg, 7770 AA

  • Novartis Investigative Site

    Maastricht, 6229 HX

  • Novartis Investigative Site

    Nijmegen

  • Novartis Investigative Site

    Rotterdam, 3045 PM

  • Novartis Investigative Site

    Sneek, The Netherlands, 8601 ZR

  • Novartis Investigative Site

    Venlo, 5912 BL

  • Novartis Investigative Site

    Zutphen, 7207 AE

Other trials in Netherlands

Slovakia15 sites

  • Novartis Investigative Site

    Banská Bystrica, 97401

  • Novartis Investigative Site

    Bratislava, 813 69

  • Novartis Investigative Site

    Bratislava, 826 06

  • Novartis Investigative Site

    Bratislava, 833 48

  • Novartis Investigative Site

    Bratislava, 851 07

  • Novartis Investigative Site

    Košice, Slovak Republic, 040 15

  • Novartis Investigative Site

    Liptovský Mikuláš, Slovak Republic, 031 23

  • Novartis Investigative Site

    Lučenec, 98439

  • Novartis Investigative Site

    Martin, 036 59

  • Novartis Investigative Site

    Nitra, 949 01

  • Novartis Investigative Site

    Nové Zámky, 940 34

  • Novartis Investigative Site

    Prešov, 081 01

  • Novartis Investigative Site

    Rimavská Sobota, 97912

  • Novartis Investigative Site

    Topoľčany, Slovak Republic, 95520

  • Novartis Investigative Site

    Trnava, 917 75

Other trials in Slovakia

Israel12 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Hadera, 38100

  • Novartis Investigative Site

    Haifa, 3525408

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Jerusalem, 91240

  • Novartis Investigative Site

    Lower Galilee, Israel, 15208

  • Novartis Investigative Site

    Nahariya, 22100

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Rehovot, 76100

  • Novartis Investigative Site

    Sefad, 13100

  • Novartis Investigative Site

    Tel Aviv, 64239

  • Novartis Investigative Site

    Tel Giborim, Holon, 58100

Other trials in Israel

Portugal11 sites

  • Novartis Investigative Site

    Amadora, 2720-276

  • Novartis Investigative Site

    Carnaxide - Linda-A-Velha, Lisbon District, 2790-134

  • Novartis Investigative Site

    Coimbra, 3000-075

  • Novartis Investigative Site

    Covilha, 6200-251

  • Novartis Investigative Site

    Lisbon, 1449-005

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Penafiel, 4564-007

  • Novartis Investigative Site

    Porto, 4200-319

  • Novartis Investigative Site

    Viana do Castelo, 4901858

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434-502

  • Novartis Investigative Site

    Vila Real, Portuigal, 5000-508

Other trials in Portugal

Australia10 sites

  • Novartis Investigative Site

    Bedford Park, South Australia, 5041

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Concord, New South Wales, 2139

  • Novartis Investigative Site

    Geelong, Victoria, 3220

  • Novartis Investigative Site

    Herston, Queensland, 4029

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

  • Novartis Investigative Site

    Perth, Western Australia, 6000

  • Novartis Investigative Site

    Randwick, New South Wales, 2031

  • Novartis Investigative Site

    St Leonards, New South Wales, 2065

Other trials in Australia

Bulgaria10 sites

  • Novartis Investigative Site

    Pazardzhik, 4400

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Smolyan, Bulgaria, 4700

  • Novartis Investigative Site

    Sofia, 1202

  • Novartis Investigative Site

    Sofia, 1407

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1606

  • Novartis Investigative Site

    Sofia, 1709

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

Austria9 sites

  • Novartis Investigative Site

    Braunau am Inn, A5280

  • Novartis Investigative Site

    Graz, A-8036

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Linz, A-4010

  • Novartis Investigative Site

    Salzburg

  • Novartis Investigative Site

    Vienna, A-1090

  • Novartis Investigative Site

    Villach, 9500

  • Novartis Investigative Site

    Wels, 4600

Other trials in Austria

Brazil9 sites

  • Novartis Investigative Site

    Curitiba, Paraná, 80730 150

  • Novartis Investigative Site

    Goiânia, Goiás, 74605-020

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14048-900

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15090-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04012 909

  • Novartis Investigative Site

    São Paulo, São Paulo, 05303-000

Other trials in Brazil

Belgium8 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Brussels, B-1070

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Mons, 7000

Other trials in Belgium

Turkey (Türkiye)7 sites

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Haydarpasa/Istanbul, 34668

  • Novartis Investigative Site

    Istanbul, 34304

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Mersin, 33079

  • Novartis Investigative Site

    Pendik / Istanbul, Turkey, 34899

  • Novartis Investigative Site

    Sivas, 58140

Other trials in Turkey (Türkiye)

Greece6 sites

  • Novartis Investigative Site

    Athens, GR, 14233

  • Novartis Investigative Site

    Athens, 11526

  • Novartis Investigative Site

    Athens, 11528

  • Novartis Investigative Site

    Chaïdári, 12461

  • Novartis Investigative Site

    Larissa, GR, 411 10

  • Novartis Investigative Site

    Thessaloniki, GR 54636

Other trials in Greece

South Africa6 sites

  • Novartis Investigative Site

    Bloemfontein, Free State, 9301

  • Novartis Investigative Site

    Durban, 4001

  • Novartis Investigative Site

    Johannesburg, 2157

  • Novartis Investigative Site

    Johannesburg, 2193

  • Novartis Investigative Site

    Umhlanga, 4320

  • Novartis Investigative Site

    Western Cape, 7130

Other trials in South Africa

Canada5 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4Z6

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4G5

  • Novartis Investigative Site

    Thetford-Mines, Quebec, G6G 2V4

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1N9

Other trials in Canada

Mexico5 sites

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80230

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44280

  • Novartis Investigative Site

    Mexico City, Mexico City, 14080

  • Novartis Investigative Site

    San Luis Potosí City, San Luis Potosí, 78240

  • Novartis Investigative Site

    San Luis Potosí City, 78200

Other trials in Mexico

Sweden5 sites

  • Novartis Investigative Site

    Jönköping, 551 85

  • Novartis Investigative Site

    Linköping, 581 85

  • Novartis Investigative Site

    Mölndal, 431 80

  • Novartis Investigative Site

    Stockholm, 17176

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Denmark4 sites

  • Novartis Investigative Site

    Copenhagen NV, DK-2400

  • Novartis Investigative Site

    Glostrup Municipality, 2600

  • Novartis Investigative Site

    Glostrup Municipality, DK-2600

  • Novartis Investigative Site

    Randers, 8930

Other trials in Denmark

Switzerland4 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Lausanne, 1011

  • Novartis Investigative Site

    Sankt Gallen, 9007

Other trials in Switzerland

Colombia3 sites

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Florida Blanca

  • Novartis Investigative Site

    Medellín, Antioquia, 050036

Other trials in Colombia

Ireland3 sites

  • Novartis Investigative Site

    Dublin, 4

  • Novartis Investigative Site

    Dublin

  • Novartis Investigative Site

    Galway

Other trials in Ireland

Chile2 sites

  • Novartis Investigative Site

    Las Condes, Santiago Metropolitan, 7560171

  • Novartis Investigative Site

    Santiago

Other trials in Chile

Norway1 site

  • Novartis Investigative Site

    Stavanger, 4068

Other trials in Norway

Peru1 site

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

Other trials in Peru

Puerto Rico1 site

  • Novartis Investigative Site

    Mayagüez, 00680

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

Read the detailed description

This Phase IIIb outcome study in AHF patients was designed as a multicenter, randomized, double-blind, placebo-controlled, event-driven study in order to assess the efficacy, safety and tolerability of intravenous infusion of serelaxin or placebo. The AHF patients randomized to either serelaxin or placebo in the study were followed for a period of 180 days, and were required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards.

Being tested
RLX030, Placebo
Keywords
acute heart failure,, AHF,, multi-center,, randomized,, double-blind

What participants receive

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

  • RLX030Drug

    1 mg/mL solution in 6 mL vials

  • PlaceboDrug

    Matching placebo solution to serelaxin

Study groups in NCT01870778
Study groupRoleWhat they receive
Serelaxin (RLX030)ExperimentalParticipants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Receives: Drug: RLX030
PlaceboPlacebo comparatorParticipants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180

    The percentage of participants with an adjudicated CV death through day 180 was assessed.

    Measured: 180 days

  2. Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5

    The percentage of participants with WHF through day 5 was assessed.

    Measured: Day 5

Secondary outcomes (8)

  1. Percentage of Participants With All-cause Death Through Day 180

    The percentage of participants with all-cause death through day 180 was assessed.

    Measured: 180 days

  2. Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization

    Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day.

    Measured: 180 days (Participants still in the hospital at Day 60 were censored at Day 60)

  3. Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization

    The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed.

    Measured: 180 days

  4. Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization

    Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day.

    Measured: 180 days (Patients still in the hospital at Day 60 were censored at Day 60)

  5. Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure

    The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema.

    Measured: From baseline to Day 5

  6. Change From Baseline in hsTroponin T Biomarker

    Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented.

    Measured: Baseline, Day 2, Day 5 and Day 14

  7. Change From Baseline in NT-proBNP Biomarker

    Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented.

    Measured: Baseline, Day 2, Day 5 and Day 14

  8. Change From Baseline in Cystatin C Biomarker

    Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented.

    Measured: Baseline, Day 2, Day 5 and 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 posted6 Jun 2013 (estimated)
  2. Study start2 Oct 2013
  3. Primary completion23 Jan 2017
  4. Study completion1 Feb 2017

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01870778
Sponsor's protocol ID
CRLX030A2301
Other IDs
2013-001498-25
Acronym
RELAX-AHF-2
Status last verified
Mar 2018
First submitted
3 Jun 2013
Last updated
30 Mar 2018
Data monitoring committee
Yes

Publications

  • Venema CS, Metra M, Staal L, Beldhuis IE, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Gimpelewicz C, Lipsic E, Voors AA, Teerlink JR, Wykrzykowska JJ. Impact of Mild and Moderate Aortic Stenosis in Acute Heart Failure: Insights From RELAX-AHF-2. J Card Fail. 2026 Feb;32(2):419-429. doi: 10.1016/j.cardfail.2025.07.017. Epub 2025 Sep 1.

    PubMed 40902819

  • Ravera A, Qin H, Ter Maaten JM, Santema BT, Adamo M, Ponikowski P, Cotter G, Davison BA, Felker GM, Filippatos GS, Pang PS, Greenberg BH, Gimpelewicz C, Severin T, Teerkink JR, Voors AA, Metra M. Clinical Presentation, Biomarker Trajectories, and Outcomes in Women and Men Hospitalized for Acute Heart Failure. JACC Heart Fail. 2025 Oct;13(10):102524. doi: 10.1016/j.jchf.2025.102524. Epub 2025 Aug 21.

    PubMed 40845614

  • Pagnesi M, Staal L, Ter Maaten JM, Beldhuis IE, Cotter G, Davison BA, Jongs N, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Lombardi CM, Adamo M, Severin T, Gimpelewicz C, Voors AA, Teerlink JR, Metra M. Decongestion and Outcomes in Patients Hospitalized for Acute Heart Failure: Insights From the RELAX-AHF-2 Trial. JACC Heart Fail. 2025 Mar;13(3):414-429. doi: 10.1016/j.jchf.2024.09.013. Epub 2024 Nov 27.

    PubMed 39614837

  • 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

  • Matsue Y, Sama IE, Postmus D, Metra M, Greenberg BH, Cotter G, Davison BA, Felker GM, Filippatos G, Pang P, Ponikowski P, Severin T, Gimpelewicz C, Voors AA, Teerlink JR. Association of Early Blood Pressure Decrease and Renal Function With Prognosis in Acute Heart Failure. JACC Heart Fail. 2021 Dec;9(12):890-903. doi: 10.1016/j.jchf.2021.07.001. Epub 2021 Oct 6.

    PubMed 34627724

  • 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

  • Loungani RS, Teerlink JR, Metra M, Allen LA, Butler J, Carson PE, Chen CW, Cotter G, Davison BA, Eapen ZJ, Filippatos GS, Gimpelewicz C, Greenberg B, Holbro T, Januzzi JL Jr, Lanfear DE, Pang PS, Pina IL, Ponikowski P, Miller AB, Voors AA, Felker GM. Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2. JACC Heart Fail. 2020 Dec;8(12):999-1008. doi: 10.1016/j.jchf.2020.09.010. Epub 2020 Nov 11.

    PubMed 33189635

  • Metra M, Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Voors AA, Adams KF, Anker SD, Arias-Mendoza A, Avendano P, Bacal F, Bohm M, Bortman G, Cleland JGF, Cohen-Solal A, Crespo-Leiro MG, Dorobantu M, Echeverria LE, Ferrari R, Goland S, Goncalvesova E, Goudev A, Kober L, Lema-Osores J, Levy PD, McDonald K, Manga P, Merkely B, Mueller C, Pieske B, Silva-Cardoso J, Spinar J, Squire I, Stepinska J, Van Mieghem W, von Lewinski D, Wikstrom G, Yilmaz MB, Hagner N, Holbro T, Hua TA, Sabarwal SV, Severin T, Szecsody P, Gimpelewicz C; RELAX-AHF-2 Committees Investigators. Effects of Serelaxin in Patients with Acute Heart Failure. N Engl J Med. 2019 Aug 22;381(8):716-726. doi: 10.1056/NEJMoa1801291.

    PubMed 31433919

  • Teerlink JR, Voors AA, Ponikowski P, Pang PS, Greenberg BH, Filippatos G, Felker GM, Davison BA, Cotter G, Gimpelewicz C, Boer-Martins L, Wernsing M, Hua TA, Severin T, Metra M. Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX-AHF-2 study. Eur J Heart Fail. 2017 Jun;19(6):800-809. doi: 10.1002/ejhf.830. Epub 2017 Apr 28.

    PubMed 28452195

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RLX030 in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 540 sites in 35 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 540 sites in United States, Germany, Argentina, Russia, Italy and 30 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. Some participants in this study may receive a placebo. 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 30 Mar 2018). 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 Confirmed Cardiovascular (CV) Death Through Day 180 (time frame: 180 days). The study lists 2 primary outcomes in all. 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 NCT01870778, which also lists 9 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 30 Mar 2018.

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