Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 4:07 PM
Study NCT ID:
NCT00520806
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2007-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012065', 'term': 'Relaxin'}], 'ancestors': [{'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2007-08-24', 'studyFirstSubmitQcDate': '2007-08-24', 'lastUpdatePostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief of dyspnea in acute heart failure', 'timeFrame': 'Up to day 5'}], 'secondaryOutcomes': [{'measure': 'Days alive and out of hospital', 'timeFrame': 'Up to day 60'}, {'measure': 'CV death or rehospitalization due to heart failure or renal failure', 'timeFrame': 'Up to day 60'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart failure', 'Renal dysfunction', 'Relaxin', 'Vasodilator'], 'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '35184572', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34514815', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '27838739', 'type': 'DERIVED', 'citation': 'Meyer S, Teerlink JR, Metra M, Ponikowski P, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Hua TA, Severin T, Qian M, Voors AA. Sex differences in early dyspnea relief between men and women hospitalized for acute heart failure: insights from the RELAX-AHF study. Clin Res Cardiol. 2017 Apr;106(4):280-292. doi: 10.1007/s00392-016-1051-4. Epub 2016 Nov 12.'}, {'pmid': '25301463', 'type': 'DERIVED', 'citation': 'Felker GM, Teerlink JR, Butler J, Hernandez AF, Miller AB, Cotter G, Davison BA, Filippatos G, Greenberg BH, Ponikowski P, Voors AA, Hua TA, Severin TM, Unemori E, Metra M. Effect of serelaxin on mode of death in acute heart failure: results from the RELAX-AHF study. J Am Coll Cardiol. 2014 Oct 14;64(15):1591-8. doi: 10.1016/j.jacc.2014.05.071.'}, {'pmid': '25287144', 'type': 'DERIVED', 'citation': 'Voors AA, Davison BA, Teerlink JR, Felker GM, Cotter G, Filippatos G, Greenberg BH, Pang PS, Levin B, Hua TA, Severin T, Ponikowski P, Metra M; RELAX-AHF Investigators. Diuretic response in patients with acute decompensated heart failure: characteristics and clinical outcome--an analysis from RELAX-AHF. Eur J Heart Fail. 2014 Nov;16(11):1230-40. doi: 10.1002/ejhf.170. Epub 2014 Oct 7.'}, {'pmid': '23141816', 'type': 'DERIVED', 'citation': 'Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Ponikowski P, Unemori E, Voors AA, Adams KF Jr, Dorobantu MI, Grinfeld LR, Jondeau G, Marmor A, Masip J, Pang PS, Werdan K, Teichman SL, Trapani A, Bush CA, Saini R, Schumacher C, Severin TM, Metra M; RELAXin in Acute Heart Failure (RELAX-AHF) Investigators. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet. 2013 Jan 5;381(9860):29-39. doi: 10.1016/S0140-6736(12)61855-8. Epub 2012 Nov 7.'}, {'pmid': '22305830', 'type': 'DERIVED', 'citation': 'Ponikowski P, Metra M, Teerlink JR, Unemori E, Felker GM, Voors AA, Filippatos G, Greenberg B, Teichman SL, Severin T, Mueller-Velten G, Cotter G, Davison BA. Design of the RELAXin in acute heart failure study. Am Heart J. 2012 Feb;163(2):149-55.e1. doi: 10.1016/j.ahj.2011.10.009.'}, {'pmid': '21622980', 'type': 'DERIVED', 'citation': 'Voors AA, Davison BA, Felker GM, Ponikowski P, Unemori E, Cotter G, Teerlink JR, Greenberg BH, Filippatos G, Teichman SL, Metra M; Pre-RELAX-AHF study group. Early drop in systolic blood pressure and worsening renal function in acute heart failure: renal results of Pre-RELAX-AHF. Eur J Heart Fail. 2011 Sep;13(9):961-7. doi: 10.1093/eurjhf/hfr060. Epub 2011 May 28.'}, {'pmid': '19329178', 'type': 'DERIVED', 'citation': 'Teerlink JR, Metra M, Felker GM, Ponikowski P, Voors AA, Weatherley BD, Marmor A, Katz A, Grzybowski J, Unemori E, Teichman SL, Cotter G. Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study. Lancet. 2009 Apr 25;373(9673):1429-39. doi: 10.1016/S0140-6736(09)60622-X. Epub 2009 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure', 'detailedDescription': 'This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized for acute heart failure\n* Dyspnea at rest or with minimal exertion\n* Pulmonary congestion\n* Able to provide informed consent\n* Systolic blood pressure \\> 125 mmHg\n* Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2\n\nExclusion Criteria:\n\n* Use of other IV therapies for acute heart failure\n* Fever or sepsis\n* Recent major neurologic event\n* Recent major surgery\n* Recent acute coronary syndrome\n* Other recent investigational drug use'}, 'identificationModule': {'nctId': 'NCT00520806', 'acronym': 'RELAX-AHF', 'briefTitle': 'Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies'}, 'officialTitle': 'A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure', 'orgStudyIdInfo': {'id': 'RLX.CHF.003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '48 hour iv infusion of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Relaxin', 'description': '48 hour iv infusion of relaxin at 30 ug/kg/day', 'interventionNames': ['Drug: Relaxin']}], 'interventions': [{'name': 'Relaxin', 'type': 'DRUG', 'description': 'Intravenous infusion for 48 h at 30 ug/kg/day', 'armGroupLabels': ['Relaxin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous infusion for 48 h', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University/Detroit Receiving Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Safed', 'country': 'Israel', 'facility': 'Heart Institute', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'overallOfficials': [{'name': 'Thomas Severin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}