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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Virginia Commonwealth University.
Recruitment status was:  Recruiting
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: August 24, 2009
Last updated: November 11, 2013
Last verified: November 2013
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: 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:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Absolute change in right ventricular ejection fraction [ Time Frame: 6 months ]
    determined by cardiac MRI

Secondary Outcome Measures:
  • right ventricular end systolic volume [ Time Frame: 6 months ]
    determined by MRI

  • 6 minute walk distance [ Time Frame: 6 months ]
  • tricuspid annular plane systolic excursion [ Time Frame: 6 months ]

Estimated Enrollment: 15
Study Start Date: June 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carvedilol Drug: Carvedilol
twice daily oral treatment in escalating dose


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

Inclusion Criteria:

  • idiopathic, familial or associated PAH, WHO group 1
  • NYHA class II or III
  • clinically stable with optimized PAH 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) > 25 mmHg
  • 6 minute walk distance (6MWD) over 100m

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.
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Please refer to this study by its identifier: NCT00964678

United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Daniel C Grinnan, MD    804-519-8705   
Principal Investigator: Daniel C Grinnan, MD         
Sponsors and Collaborators
Virginia Commonwealth University
National Center for Research Resources (NCRR)
Principal Investigator: Daniel C Grinnan, M.D Virginia Commonwealth University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University Identifier: NCT00964678     History of Changes
Other Study ID Numbers: HM12120
Study First Received: August 24, 2009
Last Updated: November 11, 2013

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists processed this record on May 22, 2017