A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol Succinate
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Gansu Provincial HospitalRecruiting
- Tongji HospitalRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- The Third Xiangya Hospital of Central South UniversityRecruiting
- Northern Jiangsu People's HospitalRecruiting
- Shengjing Hospital of China Medical UniversityRecruiting
- The First Affiliated Hospital of College of Medicine, Zhejiang UniversityRecruiting
- Taizhou HospitalRecruiting
- Beijing ANZHEN HospitalRecruiting
- China-Japan Friendship HospitalRecruiting
- Xuan Wu Hospital affiliated to Capital Medical UniversityRecruiting
- Beijing Tongren hospital affiliated to Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol Succinate
Arm Description
18-72mg/d,po
11.875-190mg/d,po
Outcomes
Primary Outcome Measures
Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
Secondary Outcome Measures
Change From Baseline in Left Ventricular End Systolic Volume Index
Change From Baseline in Left Ventricular End Diastolic Volume Index
Incidence of Hospitalizations From Exacerbation of Heart Failure
Incidence of Hospitalizations From All Causes
Incidence of Deaths From All Causes
Change From Baseline in New York Heart Association(NYHA)classification
Full Information
NCT ID
NCT02012075
First Posted
December 10, 2013
Last Updated
December 10, 2013
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02012075
Brief Title
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extended-Release Carvedilol Sulfate
Arm Type
Experimental
Arm Description
18-72mg/d,po
Arm Title
Sustained-release Metoprolol Succinate
Arm Type
Active Comparator
Arm Description
11.875-190mg/d,po
Intervention Type
Drug
Intervention Name(s)
Extended-Release Carvedilol Sulfate
Intervention Type
Drug
Intervention Name(s)
Sustained-release Metoprolol Succinate
Primary Outcome Measure Information:
Title
Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
Time Frame
Baseline and Week 36
Secondary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular End Systolic Volume Index
Time Frame
Baseline and Week 36
Title
Change From Baseline in Left Ventricular End Diastolic Volume Index
Time Frame
Baseline and Week 36
Title
Incidence of Hospitalizations From Exacerbation of Heart Failure
Time Frame
Baseline and Week 36
Title
Incidence of Hospitalizations From All Causes
Time Frame
Baseline and Week 36
Title
Incidence of Deaths From All Causes
Time Frame
Baseline and Week 36
Title
Change From Baseline in New York Heart Association(NYHA)classification
Time Frame
Baseline and Week 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changsheng Ma, Professor
Phone
86-010-64456078
Email
chshma@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changsheng Ma, Professor
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gansu Provincial Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Taizhou Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing ANZHEN Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changsheng Ma, Professor
Phone
86-010-64456078
Email
chshma@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Changsheng Ma, Professor
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Xuan Wu Hospital affiliated to Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Tongren hospital affiliated to Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
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A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure
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