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A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:
A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension

Clinical Trial Summary

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.

Clinical Trial Description

Pulmonary arterial hypertension is a medical disorder in which pressure in the blood vessels going from the right side of the heart to the lungs is higher than normal. The increased blood pressure in the lungs places a strain on the heart. This strain causes the heart to pump less blood into the lungs, causing physical symptoms of shortness of breath and tiredness. The added strain to the heart can cause physical symptoms of swelling in the feet and abdomen. These symptoms can get worse over time due to the decreased pumping ability of the heart.

This study will use a drug called ranolazine. This drug has been approved by the Food and Drug Administration (FDA) to treat chronic angina (chest pain). However, since it has not been approved for use in PAH its use in this study is considered experimental. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01757808
Study type Interventional
Source University of Chicago
Contact
Status Completed
Phase Phase 1
Start date August 2011
Completion date January 2015
View Details
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