Heart Failure | A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure
Heart Failure research study
What is the primary objective of this study?
The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus Sustained-release Metoprolol Succinate in Patients With Mild or Moderate Chronic Heart Failure.
Who is eligible to participate?
Inclusion Criteria: - Males or Females - Aged from 18 to 75 years - New York Heart Association(NYHA) classification Ⅱ-Ⅲ - At screening, subject has an LVEF<0.45 - Have received optimal therapy with an Angiotensin converting enzyme inhibitors or angiotensin receptor blocker for 4 weeks before enrollment - Subjects with symptoms of Stable heart failure do not need intravenous injection diuretics,cardiac inotropes or vasodilators - Willing to provide written informed consent Exclusion Criteria: - Current treatment on any Class I or III antiarrhythmic, except amiodarone or beta-blockers - Current treatment on calcium antagonists except for long-acting dihydropyridine agents - Have a history of acute coronary syndrome,cerebral apoplexy or transient ischemic attack with 3 months - Have a history of cardio-vascular surgery or other vessel operations with 3 months - Have a history of sustained ventricular tachycardia or ventricular fibrillation with 3 months - Have a plan to receive coronary revascularization or heart transplantation - Uncontrolled ventricular arrhythmias (not controlled with antiarrhythmic therapy or an implantable defibrillator) - Subjects with uncorrected primary obstructive or severe regurgitative valvular disease，nondilated (restrictive) or hypertrophic cardiomyopathy - Sitting systolic blood pressure≤90mmHg (based on an average of 3 readings) - Current decompensated heart failure - Second or third degree heart block，or sick sinus syndrome，a pacemaker is not placed - Contraindication to vasodilators - Have a history of cardiac resynchronization therapy or - Have received cardioverter defibrillator or pacemaker with 1 month - Resting heart rate<50 beats per minute(based on the average of 3 readings) - Elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase levels greater than 3 times upper limit of normal) - Serum creatinine levels greater than 2 times upper limit of normal - Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy - History of drug sensitivity or allergic reaction to alpha or beta-blockers - Contraindication or intolerance to beta-blockers - Pregnant or lactating women and women planning to become pregnant - Has any systemic disease, including cancer, with reduced life expectancy (<12 months) - Use of an investigational drug within 30 days of enrollment - Participation in an investigational device trial within 30 days of enrollment - Known drug or alcohol abuse 1 year prior to enrollment - Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study - In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Extended-Release Carvedilol Sulfate
Drug:Sustained-release Metoprolol Succinate
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Extended-Release Carvedilol Sulfate18-72mg/d,po
Sustained-release Metoprolol Succinate11.875-190mg/d,po
Start Date: December 2013
Phase: Phase 3
Primary Outcome: Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
Secondary Outcome: Change From Baseline in Left Ventricular End Systolic Volume Index
Study sponsors, principal investigator, and references
Principal Investigator: Changsheng Ma, Professor
Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.