Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension

This study is currently recruiting participants.

Verified July 2010 by Virginia Commonwealth University

First Received on August 24, 2009. Last Updated on July 1, 2010 History of Changes

Sponsor:	Virginia Commonwealth University
Collaborators:	GlaxoSmithKline National Center for Research Resources (NCRR)
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00964678

Purpose

The purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Carvedilol	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Carvedilol

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Absolute change in cardiac output [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

right ventricular mass [ Time Frame: 6 months ] [ Designated as safety issue: No ]
determined by MRI
6 minute walk distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
tricuspid annular plane systolic excursion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	June 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: carvedilol	Drug: Carvedilol twice daily oral treatment in escalating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

idiopathic, familial or associated PAH, WHO group 1
NYHA class III or IV
clinically stable with optimized treatment for at least 3 months
no or minimal evidence of fluid overload or volume depletion, with or without diuretic treatment
age > 18 years
mean pulmonary artery pressure (mPAP) > 40 mmHg
right atrial pressure (RAP) > 10 mmHg
6 minute walk distance (6MWD) 100-400 m

Exclusion Criteria:

Structural heart disease unrelated to PAH
Recent (<3 months) treatment with an intravenous positive inotropic agent
current use of β-blockers
history of reactive airways disease
history of adverse reaction to β-blockers
heart block on ECG or resting heart rate < 60 bpm
cardiac index < 1.8 l/min/m2
systemic hypotension (systolic pressure < 90 mmHg)
pulmonary capillary wedge pressure > 15 mmHg
inability to give informed consent
contraindications to CT and/or PET scanning
coagulopathy (INR>1.5 or platelet count<50000/mm3)
severe renal insufficiency (creatinine clearance <30 ml/min/m2)
malignancy or any co-morbidity limiting survival or conditions predicting inability to complete the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964678

Locations

United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Herman Bogaard, MD, PhD 804-628-3334 hjbogaard@vcu.edu
Principal Investigator: Herman J Bogaard, MD, PhD

Sponsors and Collaborators

Virginia Commonwealth University

GlaxoSmithKline

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Herman J. Bogaard, M.D, Ph.D.

Virginia Commonwealth University

More Information

No publications provided

Responsible Party:	Herman Bogaard, Assistant Professor of Medicine, Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00964678 History of Changes
Other Study ID Numbers:	HM12120
Study First Received:	August 24, 2009
Last Updated:	July 1, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 23, 2012