Viewing Study NCT01723371



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Last Modification Date: 2024-10-26 @ 10:58 AM
Study NCT ID: NCT01723371
Status: WITHDRAWN
Last Update Posted: 2015-12-31
First Post: 2012-10-31

Brief Title: Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
Sponsor: The Hospital for Sick Children
Organization: The Hospital for Sick Children

Study Overview

Official Title: Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
Status: WITHDRAWN
Status Verified Date: 2015-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Due to lack of enrollment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None