Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure (ZS-01-210)
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ClinicalTrials.gov Identifier: NCT01251406 |
Recruitment Status
:
Completed
First Posted
: December 1, 2010
Last Update Posted
: August 6, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Heart Failure | Drug: Placebo Drug: rhNRG-1 Dose 1 Drug: rhNRG-1 Dose 2 | Phase 2 |
This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure.
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Parallel, Placebo-controlled, Double-blind Phase IIa Study of Efficacy and Safety of Recombinant Human Neuregulin-1 (Neucardin) in Subjects With Stable Chronic Heart Failure |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Drug: Placebo
Daily subcutaneous administration for 8 hours a day for 10 days
|
Experimental: rhNRG-1 Dose 1
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Drug: rhNRG-1 Dose 1
Daily subcutaneous administration for 8 hours a day for 10 days
Other Name: Neucardin
|
Experimental: rhNRG-1 Dose 2
Subcutaneous administration for 8 hours a day for 10 days
|
Drug: rhNRG-1 Dose 2
Daily subcutaneous administration for 8 hours a day for 10 days
Other Name: Neucardin
|
- Change from baseline in LVEF [ Time Frame: 30 days ]Compared to baseline and placebo
- Six (6) minute walk test [ Time Frame: Day 30, 90, 180, 365 ]Compared to baseline and placebo
- Quality of Life Questionnaire (Kansas City Cardiomyopathy Questionnaire) [ Time Frame: Day 30, 90, 180 and 365 ]Compared to baseline and placebo
- NYHA class status [ Time Frame: Day 30, 90, 180 and 365 ]Compared to baseline and placebo
- All cause mortality and all cause hospitalization [ Time Frame: Days 30, 90, 180 and 365 ]Compared to baseline and placebo
- Change in LVESV and LVEDV [ Time Frame: Day 30 ]Compared to baseline and placebo

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years.
- 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 chronic heart failure classified as NYHA Class I or IV.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251406
United States, California | |
University of California, San Diego | |
La Jolla, California, United States, 92037 | |
Metabolic Clinic and Research Center | |
Los Angeles, California, United States, 90033 | |
USC Cardiovascular Division | |
Los Angeles, California, United States, 90033 | |
Orange County Research Center | |
Tustin, California, United States, 92780 | |
United States, Colorado | |
University of Colorado Denver | |
Denver, Colorado, United States, 80045 | |
United States, Florida | |
Clearwater Cardiovascular & Interventional Consultants, MD, PA | |
Clearwater, Florida, United States, 33756 | |
University of South Florida | |
Tampa, Florida, United States, 33606 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, Louisiana | |
MedPharmics, LLC. | |
Kenner, Louisiana, United States, 70065 | |
Benchmark Research | |
Metairie, Louisiana, United States, 70006 | |
United States, Texas | |
East Texas Cardiology | |
Houston, Texas, United States, 77002 | |
The Medical Center of Plano | |
Plano, Texas, United States, 75075 | |
United States, Virginia | |
Sentara Cardiovascular Research Institute | |
Norfolk, Virginia, United States, 23507 |
Study Chair: | Barry Greenberg, MD | University of California, San Diego | |
Principal Investigator: | Uri Elkayam, MD | LAC+USC Medical Center |
Publications:
Responsible Party: | Zensun Sci. & Tech. Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01251406 History of Changes |
Other Study ID Numbers: |
ZS-01-210 |
First Posted: | December 1, 2010 Key Record Dates |
Last Update Posted: | August 6, 2014 |
Last Verified: | August 2014 |
Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
Stable Chronic Heart Failure Systolic |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |