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