Ignite Creation Date:
2024-05-05 @ 9:15 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00840463
Status:
TERMINATED
Last Update Posted:
2020-05-19
First Post:
2009-02-06
Brief Title:
Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Safety and Efficacy Trial Using Ambrisentan for Pulmonary Hypertension Associated With Congestive Heart Failure With Preserved Left Ventricular Ejection Fraction
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrolment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 to ambrisentan or placebo The ambrisentan or matching placebo will be started at 25 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
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 capacity and improved functional class with an acceptable safety profile compared with placebo treated patients
Objectives to evaluate the safety and efficacy of ambrisentan treatment in patients with pulmonary hypertension due to diastolic CHF Efficacy will be assessed by improvement in hemodynamics PVRPulmonary Vascular Resistance primary efficacy endpoint six minute walk distance 6MWD World Health Organization WHO functional class and quality of life after 16 weeks of treatment with ambrisentan Safety of ambrisentan will be compared to placebo
Concomitant Medication Treatment with standard medications for CHF including diuretics and optimal blood pressure control with antihypertensive medications will be allowed throughout the study period Diuretics adjustment will also be allowed and encouraged based on the planned diuretic management protocol Approved medications for CHF in general are allowed as well though it should be noted that there are no medications shown to have benefit in diastolic CHF Patients may not be on an endothelin antagonist or sildenafil
Objectives to evaluate the safety and efficacy of ambrisentan treatment in patients with pulmonary hypertension due to diastolic CHF Efficacy will be assessed by improvement in hemodynamics PVRPulmonary Vascular Resistance primary efficacy endpoint six minute walk distance 6MWD World Health Organization WHO functional class and quality of life after 16 weeks of treatment with ambrisentan Safety of ambrisentan will be compared to placebo
Concomitant Medication Treatment with standard medications for CHF including diuretics and optimal blood pressure control with antihypertensive medications will be allowed throughout the study period Diuretics adjustment will also be allowed and encouraged based on the planned diuretic management protocol Approved medications for CHF in general are allowed as well though it should be noted that there are no medications shown to have benefit in diastolic CHF Patients may not be on an endothelin antagonist or sildenafil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None