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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00964678
First Posted: August 25, 2009
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Virginia Commonwealth University
  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: Intervention Model: Single Group Assignment
Masking: None (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: baseline, 6 months ]
    Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only


Secondary Outcome Measures:
  • Change in Right Ventricular End Systolic Volume [ Time Frame: baseline and 6 months ]
    right ventricular end systolic volume determined by MRI

  • Change in 6 Minute Walk Distance [ Time Frame: baseline and 6 months ]
  • Change in Tricuspid Annular Plane Systolic Excursion [ Time Frame: baseline and 6 months ]
    Higher values indicate a better outcome.


Enrollment: 10
Study Start Date: June 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carvedilol
Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
Drug: Carvedilol
twice daily oral treatment in escalating dose
Other Name: Coreg

Detailed Description:
Patients with pulmonary arterial hypertension (PAH) will be treated with carvedilol for 24 weeks. During this time, carvedilol will be titrated from an initial dose of 3.125mg BID to a maximal dose of 25mg BID. At the start and end of the study, we will obtain cardiac MRI, 6 minute walk distance, brain natriuretic peptide (serum), echocardiogram, and functional class assessment. Our primary outcome is a change in right ventricular ejection fraction with cardiac MRI.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964678


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
GlaxoSmithKline
Investigators
Principal Investigator: Daniel C Grinnan, M.D Virginia Commonwealth University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00964678     History of Changes
Other Study ID Numbers: HM12120
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: December 10, 2015
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Carvedilol
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