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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
Sponsor:
Collaborators:
GlaxoSmithKline
National Center for Research Resources (NCRR)
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00964678
First received: August 24, 2009
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  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:

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, 2013