Ignite Creation Date:
2024-05-06 @ 7:16 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02507011
Status:
TERMINATED
Last Update Posted:
2020-06-16
First Post:
2015-07-22
Brief Title:
Beta-blockers in Pulmonary Arterial Hypertension
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Beta-blockers in Pulmonary Arterial Hypertension - A Phase 2 Double-Blind Placebo-Controlled Crossover Study Evaluating the Efficacy and Safety of Carvedilol for Right Ventricular Dysfunction in Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will conduct a randomized phase 2 placebo-controlled double-blinded crossover trial of carvedilol in 26 PAH patients with World Health Organization functional class II or III symptoms and RV ejection fraction EF 45 for 6 months
Detailed Description:
Adult PAH patients on a stable dose of an approved PAH medication will undergo the following baseline assessments cardiac magnetic resonance imaging MRI right heart catheterization RHC echocardiogram 6-minute walk test 6-MWT plasma NT-ProBNP biomarkers of RV function and serum catecholamine measure of sympathetic activation and quality of life Patients will be randomized to carvedilol 3125 mg bid and escalated to 9375 mg bid as tolerated over 3 months or placebo in a 11 fashion After 6 months testing is repeated and patients are crossed over to the alternate treatment Testing is repeated at the end of the study month 13
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