Beta-blockers in Pulmonary Arterial Hypertension

• Status: Terminated
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Adrenergic beta-Antagonists; Carvedilol

Criteria

Inclusion Criteria:

• Age > 18 years

• WHO category 1 pulmonary arterial hypertension (Nice 2013)

• WHO functional class II-III

• RVEF by cardiac MRI < 45%

• Stable on PAH-specific therapy as defined by no change in PAH-specific treatment and functional class in the past 3 months. Patient can be on either mono or combination PAH-specific therapy

Exclusion Criteria:

• Subjects will be excluded from participation in the study if any of the following conditions exist:

• Significant persistent bradycardia (resting heart rate < 60 bpm) without a permanent pacemaker

• Second or third degree AV block without a permanent pacemaker

• Significant sinus tachycardia (resting heart rate > 110 bpm)

• Use of anti-arrhythmic drugs

• Hypotension defined as systolic blood pressure < 100 mmHg at the time of enrollment

• Significant illness in the past 30 days requiring hospitalization

• Acute decompensated right heart failure within past 30 days

• Known allergy or intolerance to carvedilol or other β blockers

• Cardiac index < 2 l/min/m2 or right atrial pressure > 15 mm Hg by right heart catheterization within last 3 months

• Asthma

• Positive pregnancy test in patients of child bearing-potential