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Beta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and Safety
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
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: 1.1 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 (3.25 mg/kg bid escalating to 25 mg/kg 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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
University of Minnesota
Minneapolis, Minnesota, United States
Start Date
May 1, 2014
Primary Completion Date
June 1, 2015
Completion Date
June 1, 2016
Last Updated
July 12, 2019
5
ACTUAL participants
Carvedilol
DRUG
Lead Sponsor
University of Minnesota
NCT07073820
NCT06899815
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07462260