Beta-blockers in Pulmonary Arterial Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2016 |
| End Date: | June 2019 |
Beta-blockers in Pulmonary Arterial Hypertension - A Phase 2 Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy, and Safety of Carvedilol for Right Ventricular Dysfunction in Pulmonary Arterial Hypertension
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.
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.
Adult PAH patients on a stable dose of an approved PAH medication will undergo the following
baseline assessments: cardiac magnetic resonance imaging (MRI), right heart catheterization
(RHC), echocardiogram, 6-minute walk test (6-MWT), plasma NT-ProBNP (biomarkers of RV
function) and serum catecholamine (measure of sympathetic activation), and quality of life.
Patients will be randomized to carvedilol (3.125 mg bid and escalated to 9.375 mg bid, as
tolerated, over 3 months) or placebo in a 1:1 fashion. After 6 months, testing is repeated
and patients are crossed over to the alternate treatment. Testing is repeated at the end of
the study (month 13).
baseline assessments: cardiac magnetic resonance imaging (MRI), right heart catheterization
(RHC), echocardiogram, 6-minute walk test (6-MWT), plasma NT-ProBNP (biomarkers of RV
function) and serum catecholamine (measure of sympathetic activation), and quality of life.
Patients will be randomized to carvedilol (3.125 mg bid and escalated to 9.375 mg bid, as
tolerated, over 3 months) or placebo in a 1:1 fashion. After 6 months, testing is repeated
and patients are crossed over to the alternate treatment. Testing is repeated at the end of
the study (month 13).
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
We found this trial at
1
site
Minneapolis, Minnesota 55455
Principal Investigator: Thenappan Thenappan, MD
Phone: 612-626-6237
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