Beta-blockers in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02507011
• Date of registration: 22/07/2015
• Prospective Registration: Yes
• Primary sponsor: University of Minnesota
• Public title: Beta-blockers in Pulmonary Arterial Hypertension
• Scientific 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
• Date of first enrolment: January 31, 2016
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02507011
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Thenappan Thenappan, MD
• Affiliation: University of Minnesota

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Placebo

Drug: Carvedilol

Primary Outcome(s)

Mean Change in Right Ventricular Ejection Fraction as Measured by Cardiac MRI [Time Frame: 6 months]

Secondary ID(s)

1504M69361

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02507011