Who is sponsoring NCT00840463?

NCT00840463 is sponsored by University of Texas Southwestern Medical Center.

What condition does NCT00840463 study?

NCT00840463 studies Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction.

What drugs are being tested in NCT00840463?

Interventions: Ambrisentan, Placebo.

What is the status of NCT00840463?

NCT00840463 is currently TERMINATED.

Last reviewed 2020-05-15 · How we verify

Safety and Efficacy Trial Using Ambrisentan for Pulmonary Hypertension Associated With Congestive Heart Failure With Preserved Left Ventricular Ejection Fraction

NCT00840463 Phase 4 TERMINATED Results posted

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.

Details

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 4
Status	TERMINATED
Enrolment	4
Start date	2009-01
Completion	2014-01

Conditions

Pulmonary Hypertension
Heart Failure With Preserved Ejection Fraction

Interventions

Ambrisentan
Placebo

Primary outcomes

Change in Pulmonary Vascular Resistance (Wood Units) — Baseline and Four months
The primary efficacy outcome will be Pulmonary Vascular Resistance.PVR will be calculated as \[(PA mean - wedge) / Cardiac Output\]
Safety Assessment-Number of Subjects Who Are Free and Those Who Developed Clinically Significant Adverse Events (CSAEs) — 4 months
Freedom from clinically significant adverse events will be measure by determining the number free from CSAEs and those who developed CSAEs

Countries

United States