Beta-blockers in Pulmonary Arterial Hypertension
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT02507011
- Run by
- University of Minnesota
- People needed
- 2
- Starts
- 2016-01-31
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2020-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Minnesota Medical Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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