Safety and Efficacy Study of Carvedilol to Treat Children With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): carvedilol; placebo; carvedilol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): low-dose carvedilol administered twice daily for 8 months; administered twice daily for 8 months; high-dose carvedilol administered twice daily for 8 months
Other intervention name(s): Coreg; Coreg
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent; Adrenergic alpha-Antagonists/therapeutic use; Adrenergic alpha-Antagonists/pharmacokinetics; Adrenergic alpha-Antagonists/administration & dosage; Adrenergic beta-Antagonists/therapeutic use; Adrenergic beta-Antagonists/pharmacokinetics; Adrenergic beta-Antagonists/administration & dosage; Age Factors; Carbazoles/therapeutic use; Carbazoles/administration & dosage; Child; Child, Preschool; Drug Administration Schedule; Female; Heart Failure, Congestive/etiology; Heart Failure, Congestive/drug therapy; Heart Failure, Congestive/blood; Human; Infant; Infant, Newborn; Male; Natriuretic Peptide, Brain/blood; Placebos; Propanolamines/therapeutic use; Propanolamines/administration & dosage; Prospective Studies; Support, Non-U.S. Gov't; Treatment Outcome; Ventricular Dysfunction/drug therapy; Ventricular Dysfunction/complications; Ventricular Dysfunction/blood; Ventricular Function/drug effects; Ventricular Remodeling/drug effects