drugset / Trial / NCT01723371

Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children

NCT01723371

Phase 1/2 Withdrawn The Hospital for Sick Children
NaSingle-groupOpen-labelTreatment

Summary

This study will determine the safety and feasibility of using a β-blocker (in this case carvedilol) in the treatment of pediatric patients with Left Heart Failure (LHF) in children with Pulmonary Arterial Hypertension (PAH). Carvedilol affects the nervous system, the same system that is highly activated in response to stress in patients with PAH. Each patient is administered a dosage of carvedilol, according to their weight. This dosage is increased incrementally over the span of the study, if the patient responds well to the drug. The study will determine whether the potential adverse side effects of carvedilol outweigh the possible positive results in reducing LHF. The hypothesis of this study predicts that carvedilol will have positive effects in treating LHF, similar to their use in treatment of Right Heart Failure (RHF). This is a single-centered pilot study. Each patient will be studied for approximately 31 weeks.

Timeline

Start
2012-09
Primary completion
2015-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Carvedilol Other / unclassified 0.8 mg/kg Oral
Subject Carvedilol Other / unclassified 50 mg Oral