Status:
TERMINATED
Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
Pulmonary Hypertension
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ambrise...
Detailed Description
Hypothesis: patients with pulmonary hypertension secondary to diastolic congestive heart failure (CHF) treated with ambrisentan for 16 weeks will have improved hemodynamics, increased exercise capacit...
Eligibility Criteria
Inclusion
- Catheterization
- Elevated pulmonary arterial pressure (PA mean \>25mmHg)
- Elevated pulmonary vascular resistance (\>240 dynes.cm.sec-5) or transpulmonary gradient (\>12 mmHg)
- Elevated LVEDP (\>15mmHg, but ≤23 mmHg)
- Evidence of left ventricular diastolic dysfunction: LA\>4.0, LVH or diastolic dysfunction by mitral filling pattern
- Echocardiogram: Normal or mildly reduced LV ejection fraction (greater than or equal to 40%)
- Symptomatic chronic HF (WHO functional class II-IV)
- Baseline walk distance 100 to 400 meters
- Age 18 - 80 (increased from 70)
- Maximal treatment of diastolic dysfunction as noted by the treating physicians with no change in medical therapy for one month prior to entry
Exclusion
- Use of endothelin receptor antagonist, prostacyclin or PDE-5 inhibitor within 4 weeks of enrollment
- Exercise capacity limited by other illness (other lung disease, arthritis, mobility limitations)
- Uncontrolled systemic hypertension
- Uncontrolled atrial fibrillation
- Severe valvular disease
- Pregnant females- females of child bearing potential will need to use contraceptive agent barrier given the teratogenicity associated with ERA's
- Uncontrolled OSA
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00840463
Start Date
January 1 2009
End Date
January 1 2014
Last Update
May 19 2020
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8550