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Chronic Heart FailurePhase 2ZS-01-210NCT01251406

Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure

A Phase 2 study testing rhNRG-1 Dose 1 and rhNRG-1 Dose 2 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 13 sites in United States.

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 mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1 (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged heart muscle cells to restore their structure and function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
rhNRG-1 Dose 1 and rhNRG-1 Dose 2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
13 sitesUnited States
Study dates
Jan 2012to Mar 2014
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Clearwater Cardiovascular & Interventional Consultants, MD, PA

    Clearwater, Florida, 33756

  • University of Colorado Denver

    Denver, Colorado, 80045

  • East Texas Cardiology

    Houston, Texas, 77002

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • MedPharmics, LLC.

    Kenner, Louisiana, 70065

  • University of California, San Diego

    La Jolla, California, 92037

  • Metabolic Clinic and Research Center

    Los Angeles, California, 90033

  • USC Cardiovascular Division

    Los Angeles, California, 90033

  • Benchmark Research

    Metairie, Louisiana, 70006

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • The Medical Center of Plano

    Plano, Texas, 75075

  • University of South Florida

    Tampa, Florida, 33606

  • Orange County Research Center

    Tustin, California, 92780

Other trials in United States

About this study

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

The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1 (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged heart muscle cells to restore their structure and function. This study will investigate the safety and efficacy of rhNRG-1 to treat stable chronic heart failure.

Read the detailed description

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.

Being tested
Placebo, rhNRG-1 Dose 1, rhNRG-1 Dose 2
Keywords
Stable, Chronic Heart Failure, Systolic
Medical subject headings
Systolic Murmurs

What participants receive

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

  • PlaceboDrug

    Also called Placebo: 0 dose

    Daily subcutaneous administration for 8 hours a day for 10 days

  • rhNRG-1 Dose 1Drug

    Also called Neucardin

    Daily subcutaneous administration for 8 hours a day for 10 days

  • rhNRG-1 Dose 2Drug

    Also called Neucardin

    Daily subcutaneous administration for 8 hours a day for 10 days

Study groups in NCT01251406
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubcutaneous administration for daily for 8 hours a day for 10 days
Receives: Drug: Placebo
rhNRG-1 Dose 1ExperimentalSubcutaneous administration for daily for 8 hours a day for 10 days
Receives: Drug: rhNRG-1 Dose 1
rhNRG-1 Dose 2ExperimentalSubcutaneous administration for 8 hours a day for 10 days
Receives: Drug: rhNRG-1 Dose 2

What is being measured

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

  1. Change from baseline in LVEF

    Compared to baseline and placebo

    Measured: 30 days

Secondary outcomes (5)

  1. Six (6) minute walk test

    Compared to baseline and placebo

    Measured: Day 30, 90, 180, 365

  2. Quality of Life Questionnaire (Kansas City Cardiomyopathy Questionnaire)

    Compared to baseline and placebo

    Measured: Day 30, 90, 180 and 365

  3. NYHA class status

    Compared to baseline and placebo

    Measured: Day 30, 90, 180 and 365

  4. All cause mortality and all cause hospitalization

    Compared to baseline and placebo

    Measured: Days 30, 90, 180 and 365

  5. Change in LVESV and LVEDV

    Compared to baseline and placebo

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2010 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2012
  4. Study completionMar 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01251406
Sponsor's protocol ID
ZS-01-210
Acronym
ZS-01-210
Status last verified
Jan 2025
First submitted
17 Nov 2010
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20933198

  • 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.

    PubMed 20810473

  • 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.

    PubMed 20430261

  • 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.

    PubMed 17010808

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhNRG-1 Dose 1 and rhNRG-1 Dose 2 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 13 sites in United States.

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 10 inclusion and 5 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in LVEF (time frame: 30 days). 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 NCT01251406, which also lists 4 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 10 Feb 2025.

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