A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure

Heart Failure Clinical Trial

Official title:

Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02012075
• Other study ID #: KWDLHF2012
• Status: Recruiting
• Phase: Phase 3
• First received: December 10, 2013
• Last updated: December 10, 2013
• Start date: December 2013

Study information

• Verified date: December 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Changsheng Ma, Professor
• Phone: 86-010-64456078
• Email: chshma[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males or Females

• Aged from 18 to 75 years

• New York Heart Association(NYHA) classification ?-?

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Extended-Release Carvedilol Sulfate

• Sustained-release Metoprolol Succinate

Locations

Country	Name	City	State
China	Beijing ANZHEN Hospital	Beijing
China	Beijing Tongren hospital affiliated to Capital Medical University	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Xuan Wu Hospital affiliated to Capital Medical University	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Taizhou Hospital	Taizhou	Zhejiang
China	Tongji Hospital	Wuhan	Hubei
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram		Baseline and Week 36	No
Secondary	Change From Baseline in Left Ventricular End Systolic Volume Index		Baseline and Week 36	No
Secondary	Change From Baseline in Left Ventricular End Diastolic Volume Index		Baseline and Week 36	No
Secondary	Incidence of Hospitalizations From Exacerbation of Heart Failure		Baseline and Week 36	No
Secondary	Incidence of Hospitalizations From All Causes		Baseline and Week 36	Yes
Secondary	Incidence of Deaths From All Causes		Baseline and Week 36	Yes
Secondary	Change From Baseline in New York Heart Association(NYHA)classification		Baseline and Week 36	No