Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan
Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This is a randomized study of ambrisentan that will last 16 weeks. The study will include
patients with diastolic heart failure and pulmonary hypertension. Patients will be randomized
(1:1) to ambrisentan or placebo. The ambrisentan or matching placebo will be started at 2.5
mg by mouth daily and increased to 5mg and then 10mg daily, if tolerated. Patients will be
seen at least monthly for 16 weeks. Adverse reactions will be reviewed and the required
monthly laboratory tests (liver function testing and pregnancy testing, if applicable), will
be performed. Patients will also complete an exercise test (six minute walk distance) and a
quality of life survey at the baseline, week 4 and week 16 visit. An echocardiogram and a
right heart catheterization and left ventricular end diastolic pressure measurement will be
performed at the 16 week visit. The primary end-point is safety, and secondary end-points
include the catheterization results, echocardiogram results, the walk distance and the
quality of life survey. The expected completion of the study is 18 months from initiation.
Ambrisentan is an FDA approved drug for PAH, but not for CHF.