Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure. (NCT03388593) | Clinical Trial Compass
UnknownPhase 3
Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure.
China1,600 participantsStarted 2018-07-23
Plain-language summary
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1\. Age between 18 and 75, gender balance (no more than 960 subjects of either gender in total 1600 subjects).
* 2\. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
* 3\. Subjects with chronic heart failure (NYHA class II OR III ).
* 4\. 600 pg/ml ≤NT-proBNP≤1700 pg/ml ( by Roche assay Kit in central lab).
* 5\. Diagnosed as chronic systolic heart failure (history, symptoms, signs), and in stable condition in the last one month.
* 6\. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for one month before randomization.
* 7\. Capable of signing the informed consent form.
Exclusion Criteria:
* 1\. New chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
* 2\. NYHA functional class I OR IV.
* 3\. NT-proBNP \< 600 pg/ml OR NT-proBNP\>1700 pg/ml (by Roche assay Kit in central lab).
* 4\. Patients with hypertrophic cardiomyopathy, rheumatic heart disease, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
* 5\. Ischemic heart failure without recanalization or with recanalization in recent six months.
* 6\. Acute MI in the last 3 months.
* 7\. Unstable angina.
* 8\. Patients with acute pulmonary edema or acute hemodynamic disorder.
* 9\. Chronic heart failure patients with acute hemodynamic disord…