Study to Evaluate the Safety of Twice Daily Oral Carvedilol
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring 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
Eligibility Criteria
Inclusion Criteria: Male or female patients with chronic symptomatic congestive heart failure (CHF) due to systemic ventricular systolic dysfunction, who are receiving standard heart failure therapy and have successfully completed the maintenance phase of the Pediatric Carvedilol Study 321. Parent or guardian of patient able and willing to give written informed consent. The written assent from children > 9 years of age is also required. Exclusion Criteria: A patient who, in the opinion of the investigator, would not benefit from open-label carvedilol. A patient who, in the opinion of the investigator, is incapable of cooperating with the requirements of this study. A patient treated with the following medications at the time of entry in the study: Monoamine oxidase (MAO) inhibitors; Calcium entry blockers; α- blockers, or labetalol; Disopyramide, flecainide, encainide, moricizine, propafenone; Intravenous inotropes such as dobutamine or intravenous vasodilator agents such as amrinone or milrinone; Intravenous CHF medications (e.g. diuretics, digoxin); Beta-blockers, other than double-blind carvedilol. Uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction. A patient with any of the following contra-indications to beta-blocker therapy: Heart rate < 2nd percentile for age; Unacceptable blood pressure. Sitting (supine in infants) systolic blood pressure must be > 85 mm Hg in teens; >75 mm Hg in school-aged children; and >65 mm Hg in infants; Sick sinus syndrome, second or third degree atrioventricular (AV) block, unless treated with a permanent pacemaker; History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (e.g., asthma) requiring therapy; Unstable insulin-dependent diabetes mellitus. Renovascular hypertension or evidence of pulmonary hypertension (pulmonary vascular resistance index > 6 Wood units m2) unresponsive to vasodilator agents such as oxygen, nitroprusside, or nitric oxide A patient with any one of these general exclusion criteria: Significant renal (serum creatinine > 2.0), hepatic (serum AST and/or ALT > 3 times upper limit of normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications; Endocrine disorders such as pheochromocytoma, active hyperthyroidism and untreated hypothyroidism; Any illness other than heart failure that may limit survival within 1 year (e.g. neoplasm); Girls of childbearing potential who are pregnant or sexually active and not taking adequate contraceptive precautions (e.g., intrauterine device [IUD] or oral contraceptives). A patient who received any investigational drug within the preceding 30 days except blinded medication in Pediatric Carvedilol Study 321. An investigational drug is defined as any agent (placebo or drug) dispensed as part of a research study.
Sites / Locations
- Mattel Children's Hospital at UCLA
- Children's Hospital Los Angeles
- Stanford University
- University of Colorado
- University of Miami
- Children's Memorial Hospital
- Children's Hospital, Boston
- C.S. Mott Children's Hospital
- Children's Hospital of Michigan
- Washington University
- Columbia University
- Children's Hospital of Philadelphia
- Vanderbilt Children's Hospital
- UT Southwestern Medical Center
- Texas Children's Hospital
- University of Utah
- Seattle Childrens Hospital and Regional Medical Center