Modulating Effects of Lisinopril on Sildenafil Activity in Pulmonary Arterial Hypertension(PAH)( MELISSA)
Completed
Conditions studied: Pulmonary Arterial Hypertension
In brief
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 nitric oxide(NO) plays a role in the pathophysiology of PAH. Phosphodiesterase Type 5 Inhibitor (PDE5 inhibitors) sildenafil have been shown to be beneficial in PAH, but extent of benefit is variable.
Key facts
- Study ID
- NCT01181284
- Run by
- Mayo Clinic
- People needed
- 24
- Starts
- 2008-05-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2012-02-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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