Status:
COMPLETED
Modulating Effects of Lisinopril on Sildenafil Activity in Pulmonary Arterial Hypertension(PAH)( MELISSA)
Lead Sponsor:
Mayo Clinic
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Brief Summary
Patients with pulmonary arterial hypertension(PAH) suffer from chronic shortness of breath, and have impaired survival related to progressive right ventricular failure. Abnormal vasoreactivity to nitr...
Detailed Description
The broad aim of this investigation is to determine whether the modulating effect of angiotensin converting enzyme inhibition on vascular smooth muscle responsiveness to the nitric oxide pathway that ...
Eligibility Criteria
Inclusion
- Age 18-75
- World Health Organization (WHO) Group I PAH with prior documentation of peripheral vascular resistance (PVR) \> 3 WU and wedge(PCW) 16 or less.
- WHO Functional Class I-III
- 6 minute walk distance 150-575 meters
- Women of child bearing potential must have a negative pregnancy test and be using effective contraception
- Receiving therapy with phosphodiesterase-5 inhibitor for PAH (sildenafil or tadalafil) for at least 3 months and with stable dose for at least 30 days
- If already receiving therapy with endothelin receptor antagonists must have been on therapy for at least 3 months and on stable dose for at least 30 days
Exclusion
- Allergy or intolerance to captopril or other angiotensin converting enzyme inhibitors
- Systemic systolic blood pressure less than 100 mm Hg
- Therapy with prostanoids (iloprost, treprostinil, epoprostenol) within preceding 3 months
- Pregnant or breast feeding
- Creatinine \> 2.0 mg/dl
- Potassium \> 5.0 meq/dl
- Unable to provide informed consent
- TLC or VC \<60% predicted
- Untreated obstructive sleep apnea
- LVEF \< 40%
- Hb \< 10 mg/dL
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01181284
Start Date
May 1 2008
End Date
July 1 2011
Last Update
February 7 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905