Beta-blockers in Pulmonary Arterial Hypertension

NCT02507011 | Terminated Phase 2 Results DMC

• 1 other identifier: 1504M69361
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Change in Right Ventricular Ejection Fraction as Measured by Cardiac MRI

  6 months

Study Arms (2)

Carvedilol First

EXPERIMENTAL

Crossover Design: Participants receive Carvedilol first and placebo second

Drug: Carvedilol; Drug: Placebo

Placebo First

PLACEBO COMPARATOR

Crossover Design: Participants receive placebo first and Carvedilol second

Drug: Carvedilol; Drug: Placebo

Interventions

Carvedilol DRUG

Beta-adrenergic receptor blocker

Also known as: Beta-blockers

Carvedilol First; Placebo First

Placebo DRUG

Placebo

Carvedilol First; Placebo First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Carvedilol; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Results Point of Contact

• Title: Thenappan Thenappan, MD
• Organization: University of Minnesota

cvheart@umn.edu

612-625-2191

Study Officials

• Thenappan Thenappan, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: January 31, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)