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

This study is currently recruiting participants.
Verified November 2013 by Virginia Commonwealth University
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00964678
First received: August 24, 2009
Last updated: November 11, 2013
Last verified: November 2013
  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:


Further study details as provided by Virginia Commonwealth University:

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


Secondary Outcome Measures:
  • right ventricular end systolic volume [ 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: 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

  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 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.
  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: Daniel C Grinnan, MD    804-519-8705    dcgrinnan@vcu.edu   
Principal Investigator: Daniel C Grinnan, MD         
Sponsors and Collaborators
Virginia Commonwealth University
GlaxoSmithKline
Investigators
Principal Investigator: Daniel C Grinnan, M.D Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00964678     History of Changes
Other Study ID Numbers: HM12120
Study First Received: August 24, 2009
Last Updated: November 11, 2013
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 April 14, 2014