Beta-blockers in Pulmonary Arterial Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02507011
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Minnesota
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Thenappan Thenappan, MD
Principal Investigator Affiliation University of Minnesota
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Additional Details

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).

Arms & Interventions

Arms

Active Comparator: carvedilol

Beta Blocker

Placebo Comparator: Placebo

General Placebo

Interventions

Drug: - Carvedilol

Beta-adrenergic receptor blocker

Drug: - Placebo

Placebo

Contact a Trial Team

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University of Minnesota Medical Center, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455

Site Contact

Gretchen Beiches, RN

612-626-6237

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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