Safety and Efficacy Study of Carvedilol to Treat Children With Congestive Heart Failure
- Registration Number
- NCT00052026
- Lead Sponsor
- Shaddy, Robert, M.D.
- Brief Summary
The purpose of this study is to determine whether a new medicine, called carvedilol, improves symptoms and heart function in children who have congestive heart failure (diminished function of their heart muscle that pumps blood to the body). To accomplish this, we will give carvedilol to some patients who have diminished heart function and congestive heart failure and see whether symptoms and heart function are better at the end of an 8 month period in those who received carvedilol compared to the other patients who did not receive carvedilol. We will be testing 2 different doses of carvedilol compared to no additional medicine.
- Detailed Description
Overactivity of the sympathetic nervous system is thought to contribute to the pathophysiology of congestive heart failure (CHF). Blockade of the sympathetic nervous system with β-adrenergic inhibitors could be expected to ameliorate these detrimental effects in a manner analogous to the effects of the angiotensin converting enzyme inhibitors on the overactive renin-angiotensin system.
Carvedilol may be superior to pure beta-blockers in the treatment of CHF through its mechanism of action of blocking not only β-receptors but also α-receptors, which would allow vasodilation to reduce the afterload on the failing heart. Since beta-blockers may initially produce a negative inotropic effect on the heart, long term treatment has been needed to show benefits of removal of the adrenergic stimulation. The investigators will monitor the safety and efficacy of carvedilol administration in children with chronic CHF due to systemic ventricular dysfunction.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Placebo 2 carvedilol Low-dose carvedilol 3 carvedilol high-dose carvedilol
- Primary Outcome Measures
Name Time Method The primary efficacy variable is a CHF composite response. 8 months
- Secondary Outcome Measures
Name Time Method Selected individual components of the CHF composite of clinical outcomes 8 months
Trial Locations
- Locations (21)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Columbia University
🇺🇸New York, New York, United States
Mattel Children's Hospital at UCLA
🇺🇸Los Angeles, California, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
NYU Medical Center
🇺🇸New York, New York, United States
C.S. Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Stanford University
🇺🇸Palo Alto, California, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Miami
🇺🇸Miami, Florida, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Childrens Hospital and Regional Medical Center
🇺🇸Seattle, Washington, United States
Children's Hospital, Boston
🇺🇸Boston, Massachusetts, United States
University of Southern Florida
🇺🇸St. Petersburg, Florida, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States