Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02120339
Status:
TERMINATED
Last Update Posted:
2019-07-12
First Post:
2014-04-17
Brief Title:
Carvedilol PAH A Pilot Study of Efficacy and Safety
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Beta Blockers in Pulmonary Arterial Hypertension PAH A Pilot Study of Efficacy and Safety
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Estimate the effect of chronic beta-adrenergic receptor blockade with carvedilol on RV function in patients with PAH
Assess the safety and tolerability of chronic carvedilol therapy in patients with PAH
Assess the safety and tolerability of chronic carvedilol therapy in patients with PAH
Detailed Description:
This is a prospective open label uncontrolled pilot study examining the safety and efficacy of beta-blocker therapy with carvedilol on RV function in stable PAH Patients with World Health Organization WHO functional class II or III symptoms and RV ejection fraction EF 40 Twenty-five evaluable patients will be enrolled at the University of Minnesota
Specific Aims
11 Primary Efficacy Endpoint Adult males and females on a stable dose of an approved PAH medication will undergo cardiac magnetic resonance imaging MRI right heart catheterization RHC echocardiogram 6-minute walk test 6-MWT measurement of plasma NT-ProBNP and serum catecholamine and quality of life assessment Patients will receive carvedilol 325 mgkg bid escalating to 25 mgkg bid over 3 months Testing is repeated at the end of the study month 6 RVEF measured by cardiac MRI is the primary efficacy endpoint We define a 5 increase in RVEF as a meaningful change
Specific Aims
11 Primary Efficacy Endpoint Adult males and females on a stable dose of an approved PAH medication will undergo cardiac magnetic resonance imaging MRI right heart catheterization RHC echocardiogram 6-minute walk test 6-MWT measurement of plasma NT-ProBNP and serum catecholamine and quality of life assessment Patients will receive carvedilol 325 mgkg bid escalating to 25 mgkg bid over 3 months Testing is repeated at the end of the study month 6 RVEF measured by cardiac MRI is the primary efficacy endpoint We define a 5 increase in RVEF as a meaningful change
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