NCT01251406: ZS-01-210

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

Completed Phase 2 Last updated 6 February 2025

What this trial tests

Phase 2 trial testing Placebo in Chronic Heart Failure in 67 participants. Completed in 1 March 2014.

Timeline

1 January 2012

Primary endpoint
1 December 2012

1 March 2014

Quick facts

Lead sponsor	Zensun Sci. & Tech. Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	67
Start date	1 January 2012
Primary completion	1 December 2012
Estimated completion	1 March 2014
Sites	13 locations across United States

Drugs / interventions tested

• Placebo
• rhNRG-1 Dose 1
• rhNRG-1 Dose 2

Conditions studied

• Chronic Heart Failure — all drugs for Chronic Heart Failure →

Sponsor

Zensun Sci. & Tech. Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Chronic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in LVEF
  Time frame: 30 days
  Compared to baseline and placebo

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuregulin as a heart failure therapy and mediator of reverse remodeling.
   Galindo CL, Ryzhov S, Sawyer DB. · · 2014 · cited 53× · PMID 24234399 · DOI 10.1007/s11897-013-0176-2
2. Neuregulin-1 inhibits neuroinflammatory responses in a rat model of organophosphate-nerve agent-induced delayed neuronal injury.
   Li Y, Lein PJ, Ford GD, Liu C, et al · · 2015 · cited 46× · PMID 25880399 · DOI 10.1186/s12974-015-0283-y
3. Human Pluripotent Stem Cell-Derived Cardiomyocytes for Assessment of Anticancer Drug-Induced Cardiotoxicity.
   Schwach V, Slaats RH, Passier R. · · 2020 · cited 33× · PMID 32322588 · DOI 10.3389/fcvm.2020.00050
4. Targeting Ca<sup>2 +</sup> Handling Proteins for the Treatment of Heart Failure and Arrhythmias.
   Njegic A, Wilson C, Cartwright EJ. · · 2020 · cited 24× · PMID 33013458 · DOI 10.3389/fphys.2020.01068
5. Heart failure-potential new targets for therapy.
   Nabeebaccus A, Zheng S, Shah AM. · · 2016 · cited 24× · PMID 27365454 · DOI 10.1093/bmb/ldw025
6. Neuregulin in Health and Disease.
   Cespedes JC, Liu M, Harbuzariu A, Nti A, et al · · 2018 · cited 17× · PMID 31032468 · DOI 10.23937/2469-5866/1410024
7. Elevated neuregulin-1<i>β</i> levels correlate with plasma biomarkers of cerebral injury and high stroke risk in children with sickle cell anemia.
   Chambliss C, Richardson T, Onyekaba J, Cespedes J, et al · · 2021 · cited 4× · PMID 35935682 · DOI 10.1016/j.endmts.2021.100088
8. The case for neuregulin-1 as a clinical treatment for stroke.
   Noll JM, Sherafat AA, Ford GD, Ford BD. · · 2024 · cited 2× · PMID 38638304 · DOI 10.3389/fncel.2024.1325630