A Multicenter, Open Label Extension Study to Evaluate the Safety of Twice Daily Oral Carvedilol in Pediatric Patients With Chronic Heart Failure
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- Shaddy, Robert, M.D.
- Enrollment
- 75
- Locations
- 17
- Primary Endpoint
- dose tolerability
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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
Investigators
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
- •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.
Outcomes
Primary Outcomes
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)