At a glance
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Proof of Concept Study of Ranolazine in the Treatment of Pulmonary Hypertension Associated With Diastolic Left Ventricular Dysfunction
In Brief
A Phase 4 clinical trial evaluating Ranolazine for Pulmonary Hypertension and Diastolic Left Ventricular Dysfunction. Completed, enrolled 10 participants across 1 site.
Detailed Summary
This is a single center, open-label trial designed to assess the safety and efficacy of ranolazine (Ranexa) in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction. All patients will receive active drug. The study includes a screening period, 6 month treatment period and a follow up period. Eligible patients who provide informed consent and who meet all inclusion/exclusion criteria will be enrolled in this study. There is neither proven therapy for patients with diastolic dysfunction-associated pulmonary hypertension nor for patients with diastolic dysfunction alone. Ranolazine, an inhibitor of cardiac repolarization (sodium channels), could represent a new and effective treatment of this entity.
Study Details
Timeline
Interventions
Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated