Study Stopped
Sponsor has designed another study with different endpoint to replace the current study
Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
1 other identifier
interventional
146
1 country
21
Brief Summary
Multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on serum NT-proBNP, as well as safety in patients with chronic heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2011
Shorter than P25 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 21, 2017
July 1, 2012
1 year
September 21, 2011
December 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NT-proBNP
30 days
Secondary Outcomes (4)
NT-proBNP
90 days
Six Minutes Walk Distance
30 days and 90 days
NYHA classification
30 days and 90 days
Quality of Life
30 days and 90 days
Study Arms (2)
rhNRG-1
ACTIVE COMPARATORRecombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
Plaebo
PLACEBO COMPARATORExcipient placebo in addition to basic therapy of chronic heart failure
Interventions
Eligibility Criteria
You may qualify if:
- Age between 18 and 75, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class II\~III.
- Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
- Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
- Capable of signing the informed consent form.
You may not qualify if:
- Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- Ischemic heart failure without recanalization or with recanalization in recent six months.
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation or has received CRT treatment.
- Serious hepatic or renal dysfunction caused by organic pathological changes (Cr\>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
- Patients need mechanical ventilation.
- Systolic blood pressure \<90mmHg or \>160mmHg.
- Patients with acute hemodynamic disorder or decompensation in the last 1 month.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- Serum potassium \<3.2 mmol/L or \>5.5 mmol/L.
- Pregnant or plan to pregnant.
- Unmarried or married but not procreated women at child-bearing age.
- Subject with a life expectancy less than 6 months as assessed by the investigator.
- Patients who participated in any clinical trial in the recent three months.
- History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing Municipality, China
Bethune Peace Hospital
Shijiazhuang, Hebei, China
Teda International Cardiovascular Hospital
Tianjin, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The First Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Sichuan Provincial People's Hospital
Chengdu, Jiangsu, China
The Second Hospital affiliated to Suzhou University
Suzhou, Jiangsu, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Affiliate Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The First Hospital affiliated to Dalian Medical University
Dalian, Liaoning, China
The first affiliated hospital of Liaoning medical college
Jinzhou, Liaoning, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
The Xinqiao Hospital of Third Military Medical University
Chongqing, Sichuan, China
Kunming General Hospital of Chengdu Military Region
Kunming, Yunnan, China
Study Officials
- PRINCIPAL INVESTIGATOR
Runlin Gao, MD, Ph.D
Cardiovascular Institute and Fuwai Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
September 21, 2011
First Posted
September 23, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
December 21, 2017
Record last verified: 2012-07