Pulmonary Hypertension Clinical Trial
Official title:
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.
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