Beta-blockers in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02507011
• Other study ID #: 1504M69361
• Status: Terminated
• Phase: Phase 2
• Start date: January 31, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Carvedilol
Beta-adrenergic receptor blocker
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Right Ventricular Ejection Fraction as Measured by Cardiac MRI		6 months