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Beta-blockers in Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02507011
Recruitment Status : Terminated (Recruitment)
First Posted : July 23, 2015
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Carvedilol Drug: Placebo Phase 2

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 31, 2016
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019


Arm Intervention/treatment
Active Comparator: carvedilol
Beta Blocker
Drug: Carvedilol
Beta-adrenergic receptor blocker
Other Name: Beta-blockers

Drug: Placebo
Placebo

Placebo Comparator: Placebo
General Placebo
Drug: Carvedilol
Beta-adrenergic receptor blocker
Other Name: Beta-blockers

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Mean change in Right Ventricular Ejection Fraction as measured by cardiac MRI [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507011


Locations
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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Thenappan Thenappan, MD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Informed Consent Form  [PDF] October 12, 2017

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02507011    
Other Study ID Numbers: 1504M69361
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists