Status:
COMPLETED
Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 o...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00964678
Start Date
June 1 2010
End Date
May 1 2014
Last Update
June 8 2017
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298