Clinical trial NCT02012075: A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure
Official title: Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-16
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
timeFrame: Baseline and Week 36
Secondary outcomes:
measure: Change From Baseline in Left Ventricular End Systolic Volume Index
timeFrame: Baseline and Week 36
measure: Change From Baseline in Left Ventricular End Diastolic Volume Index
timeFrame: Baseline and Week 36
measure: Incidence of Hospitalizations From Exacerbation of Heart Failure
timeFrame: Baseline and Week 36
measure: Incidence of Hospitalizations From All Causes
timeFrame: Baseline and Week 36
measure: Incidence of Deaths From All Causes
timeFrame: Baseline and Week 36
measure: Change From Baseline in New York Heart Association（NYHA）classification
timeFrame: Baseline and Week 36
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing ANZHEN Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Xuan Wu Hospital affiliated to Capital Medical University
city: Beijing
country: China
facility: Beijing Tongren hospital affiliated to Capital Medical University
Study officials:
affiliation: Beijing Anzhen Hospital
name: Changsheng Ma, Professor
role: PRINCIPAL_INVESTIGATOR
References: