Congestive Heart Failure
Conditions
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
Brief summary
The objective of this study is to evaluate the long-term safety of carvedilol in pediatric patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321. Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until termination of the study) by SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK) or the University Sponsor.
Detailed description
This open-label, uncontrolled, extension study is designed to assess the long-term safety of carvedilol in pediatric patients with heart failure and includes the following phases: 1. Screening Phase (coincides with the final maintenance Month 6 Visit in the 321 study 2. Down-/Up-titration Phase 3. Maintenance Phase 4. Down-titration 5. Follow-up
Interventions
DRUGCarvedilol
Sponsors
GlaxoSmithKline
Shaddy, Robert, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose tolerability | — |
| growth and development | — |
| physical exam (PE) including cardiopulmonary examination | — |
| blood pressure (BP), heart rate (HR), height (Ht) and weight [Wt] (including %) | — |
| laboratory safety assessments | — |
| pregnancy test, if applicable | — |
| an echocardiographic measurement | — |
| reporting of all adverse events [AEs] (serious and non-serious) | — |
Countries
United States
Outcome results
None listed