Pilot Study of COR-1 in Heart Failure

NCT01391507 | Completed Phase 2 Results DMC

• 3 other identifiers: CR1009132010-022579-68COR-1/02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.

Conditions

Cardiomyopathy, Dilated

Keywords

Anti-beta1-receptor autoantibodies; COR-1; Heart failure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6

  The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).

  Baseline and Month 6

Secondary Outcomes (9)

• Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9

  Baseline and Month 9

• Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6

  Baseline and Month 6

• Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6

  Baseline and Month 6

• Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6

  Baseline and Month 6

• Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6

  Baseline and Month 6

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: 0.9 % sodium chloride; Drug: Standard therapy for heart failure

20 mg COR-1

EXPERIMENTAL

Drug: COR-1; Drug: Standard therapy for heart failure

80 mg COR-1

EXPERIMENTAL

Drug: COR-1; Drug: Standard therapy for heart failure

160 mg COR-1

EXPERIMENTAL

Drug: COR-1; Drug: Standard therapy for heart failure

Interventions

0.9 % sodium chloride DRUG

Monthly intravenous injection for 6 months

Placebo

COR-1 DRUG

Monthly intravenous injection for 6 months

160 mg COR-1; 20 mg COR-1; 80 mg COR-1

Standard therapy for heart failure DRUG

All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study.

160 mg COR-1; 20 mg COR-1; 80 mg COR-1; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed heart failure due to dilated cardiomyopathy with left ventricular ejection fraction \< 45%
• Presence of anti-beta1-receptor autoantibodies
• New York Heart Association (NYHA) class II to III heart failure
• Symptomatic heart failure for \>1 year and \< 8 years
• Treatment with adequate doses of angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta-blockers, and optional aldosterone antagonists according to guidelines for at least six months (with the exception of lack of tolerability of any of these drugs) and at stable doses for 2 months prior to screening

You may not qualify if:

• Ischemic heart disease characterized by \>= 50% coronary artery stenosis and/or history of myocardial infarction
• Third or higher degree valvular defect
• Any disease requiring immunosuppressive drugs (except for \<= 5 mg/day prednisone-equivalent dose) or any clinically relevant disorder of the immune system
• History of severe allergies and increased risk for anaphylactic shock (e.g., bronchial asthma)
• History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results

Sponsors & Collaborators

• Corimmun GmbH: lead

Study Sites (4)

Unknown Facility

München, Germany

Location

Unknown Facility

Regensburg, Germany

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Würzburg, Germany

Location

Related Publications (4)

• Jahns R, Boivin V, Siegmund C, Inselmann G, Lohse MJ, Boege F. Autoantibodies activating human beta1-adrenergic receptors are associated with reduced cardiac function in chronic heart failure. Circulation. 1999 Feb 9;99(5):649-54. doi: 10.1161/01.cir.99.5.649.

  PMID: 9950662 BACKGROUND

• Stork S, Boivin V, Horf R, Hein L, Lohse MJ, Angermann CE, Jahns R. Stimulating autoantibodies directed against the cardiac beta1-adrenergic receptor predict increased mortality in idiopathic cardiomyopathy. Am Heart J. 2006 Oct;152(4):697-704. doi: 10.1016/j.ahj.2006.05.004.

  PMID: 16996841 BACKGROUND

• Iwata M, Yoshikawa T, Baba A, Anzai T, Mitamura H, Ogawa S. Autoantibodies against the second extracellular loop of beta1-adrenergic receptors predict ventricular tachycardia and sudden death in patients with idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2001 Feb;37(2):418-24. doi: 10.1016/s0735-1097(00)01109-8.

  PMID: 11216956 BACKGROUND

• Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):480-6. doi: 10.1161/CIRCULATIONAHA.108.191259. No abstract available.

  PMID: 19171871 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Interventions

Sodium Chloride; Standard of Care

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Due to the decision to amend protocol to a pilot study coupled with the high study agent discontinuation rate, safety or efficacy of JNJ-54452840 could not be concluded due to the insufficient sample size and drug exposure to investigational agent.

Results Point of Contact

• Title: Associate Director Biostatistics
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Corimmun GmbH Clinical Trial

  Corimmun GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: July 12, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 17, 2014
• Results First Posted: August 26, 2014

Record last verified: 2014-10

Locations

DE (4)