A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
Abstract
The purpose of this study is to assess the safety of ranolazine in people with pulmonary arterial hypertension (PAH) and who are receiving 1 or more background PAH therapies: ambrisentan, sildenafil,tadalafil, epoprostenol, treprostinil (IV, SC, inhaled), or iloprost. The primary objective is:
* To estimate the effect of ranolazine administration on acute hemodynamics.
* To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after 12 weeks of therapy
* To assess changes in right ventricular function after 12 weeks of therapy.
Conditions: Pulmonary Arterial Hypertension.
Primary outcome: Change in pulmonary vascular resistance (PVR).
Enrollment: 12 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
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