Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2010 |
| End Date: | May 2014 |
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.
pulmonary arterial hypertension and associated right heart failure is safe and results in an
improved function of the right heart.
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.
We found this trial at
1
site
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
Click here to add this to my saved trials
