View Clinical Trial (Medical Research Study)
Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
| City: |
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Richmond |
| State: |
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Virginia |
| Zip Code: |
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23298 |
| Conditions: |
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Pulmonary Arterial Hypertension |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT00964678 |
| Primary Contact: |
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Principal Investigator
Herman J. Bogaard, M.D, Ph.D.
Virginia Commonwealth University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Richmond, Virginia 23298
United States
Herman Bogaard, MD, PhD
Phone: 804-628-3334
Email: hjbogaard@vcu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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