Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure
NCT ID: NCT01251406
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2012-01-31
2014-03-31
Brief Summary
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Detailed Description
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A total of 120 subjects, who have chronic heart failure with a NYHA classification of II or III, and are on a stable regimen of ACEI/angiotensin receptor blocker (ARB), beta-blocker, and/or diuretic for at least 3 months prior to receiving study medication and anticipated to remain on the stable regimen through the treatment period can enroll as per specific inclusion and exclusion criteria.
Subjects will be hospitalized for 10 days during the treatment period and will be infused subcutaneously with rhNRG-1 or placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Subcutaneous administration for daily for 8 hours a day for 10 days
Placebo
Daily subcutaneous administration for 8 hours a day for 10 days
rhNRG-1 Dose 1
Subcutaneous administration for daily for 8 hours a day for 10 days
rhNRG-1 Dose 1
Daily subcutaneous administration for 8 hours a day for 10 days
rhNRG-1 Dose 2
Subcutaneous administration for 8 hours a day for 10 days
rhNRG-1 Dose 2
Daily subcutaneous administration for 8 hours a day for 10 days
Interventions
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Placebo
Daily subcutaneous administration for 8 hours a day for 10 days
rhNRG-1 Dose 1
Daily subcutaneous administration for 8 hours a day for 10 days
rhNRG-1 Dose 2
Daily subcutaneous administration for 8 hours a day for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female subjects.
* Have chronic heart failure defined as NYHA classification of II or III.
* Be on a stable regimen of ACEI/ARB and/or beta-blocker 3 months prior to receiving study medication and are expected to remain on a stable HF medication regime throughout the duration of the trial.
* Left ventricular ejection fraction (LVEF) of \< 35% as determined at screening by 2-D echocardiography.
* Is able to understand and provide informed consent.
* If subject has dilated cardiomyopathy, ischemic heart disease or corrected valvular heart disease, and had surgery to repair or replace value, the surgery must have been performed 3 months prior to receiving study medication and the surgical area is functioning normally.
* Proper birth control must be used at least 3 weeks prior to the study (women only), during the infusion period of study drug (men and women), 4-weeks after study drug administration (men and women) and the remaining 11 months in the study follow-up (women). Women must have a negative pregnancy test at screening.
* No greater than mild pericardial effusion \< 0.5 cm on echocardiography (roughly corresponds to \< 100 mL).
* Have an implantable cardioverter-defibrillator (ICD). The ICD should have been implanted at least 3 months prior to receiving study medication. Patients should undergo interrogation of their ICDs between 1 and 7 days before randomization to drug for the previous thirty (30) days. This interrogation would include surveillance for ventricular arrhythmias as well as assessment of ICD discharge(s) and/or anti-tachycardia pacing.
Exclusion Criteria
* Has a history of any malignancy or positive test as specified in the pre-cancer screening.
* Have other conditions which in the opinion of the investigator preclude participation in the study, e.g. serious co-morbidity, known or suspected substance abuse or non-compliance.
* Has a body weight \>350lbs.
* Has had any cause hospitalization 30 days prior to screening.
18 Years
ALL
No
Sponsors
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Zensun USA Inc.
INDUSTRY
Zensun Sci. & Tech. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Barry Greenberg, MD
Role: STUDY_CHAIR
University of California, San Diego
Uri Elkayam, MD
Role: PRINCIPAL_INVESTIGATOR
LAC+USC Medical Center
Locations
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University of California, San Diego
La Jolla, California, United States
Metabolic Clinic and Research Center
Los Angeles, California, United States
USC Cardiovascular Division
Los Angeles, California, United States
Orange County Research Center
Tustin, California, United States
University of Colorado Denver
Denver, Colorado, United States
Clearwater Cardiovascular & Interventional Consultants, MD, PA
Clearwater, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
MedPharmics, LLC.
Kenner, Louisiana, United States
Benchmark Research
Metairie, Louisiana, United States
East Texas Cardiology
Houston, Texas, United States
The Medical Center of Plano
Plano, Texas, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Countries
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References
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Xu Y, Li X, Liu X, Zhou M. Neuregulin-1/ErbB signaling and chronic heart failure. Adv Pharmacol. 2010;59:31-51. doi: 10.1016/S1054-3589(10)59002-1.
Jabbour A, Hayward CS, Keogh AM, Kotlyar E, McCrohon JA, England JF, Amor R, Liu X, Li XY, Zhou MD, Graham RM, Macdonald PS. Parenteral administration of recombinant human neuregulin-1 to patients with stable chronic heart failure produces favourable acute and chronic haemodynamic responses. Eur J Heart Fail. 2011 Jan;13(1):83-92. doi: 10.1093/eurjhf/hfq152. Epub 2010 Sep 1.
Gao R, Zhang J, Cheng L, Wu X, Dong W, Yang X, Li T, Liu X, Xu Y, Li X, Zhou M. A Phase II, randomized, double-blind, multicenter, based on standard therapy, placebo-controlled study of the efficacy and safety of recombinant human neuregulin-1 in patients with chronic heart failure. J Am Coll Cardiol. 2010 May 4;55(18):1907-14. doi: 10.1016/j.jacc.2009.12.044.
Liu X, Gu X, Li Z, Li X, Li H, Chang J, Chen P, Jin J, Xi B, Chen D, Lai D, Graham RM, Zhou M. Neuregulin-1/erbB-activation improves cardiac function and survival in models of ischemic, dilated, and viral cardiomyopathy. J Am Coll Cardiol. 2006 Oct 3;48(7):1438-47. doi: 10.1016/j.jacc.2006.05.057. Epub 2006 Sep 14.
Other Identifiers
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ZS-01-210
Identifier Type: -
Identifier Source: org_study_id
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