Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Information source: Virginia Commonwealth University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Arterial Hypertension
Intervention: Carvedilol (Drug); placebo (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s):
Herman J. Bogaard, M.D, Ph.D., Principal Investigator, Affiliation: Virginia Commonwealth University
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 of the right heart.
Clinical Details
Official title: Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Absolute change in cardiac output
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Herman Bogaard, MD, PhD, Phone: 804-628-3334, Email: hjbogaard@vcu.edu
Herman J Bogaard, MD, PhD, Principal Investigator
Additional Information
Starting date: August 2009
Ending date: September 2011
Last updated: August 24, 2009
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