Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00840463|
Recruitment Status : Terminated (Poor enrolment)
First Posted : February 10, 2009
Results First Posted : May 22, 2019
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Heart Failure With Preserved Ejection Fraction||Drug: Ambrisentan Other: Placebo||Phase 4|
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 (PVR(Pulmonary 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety and Efficacy Trial Using Ambrisentan for Pulmonary Hypertension Associated With Congestive Heart Failure With Preserved Left Ventricular Ejection Fraction|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||January 2014|
|Active Comparator: 1||
Subjects will be initiated at 2.5 mg per day and increased to 5mg daily in 2 weeks and then 10mg daily if clinically tolerated (edema is controlled and symptoms are stable).
Other Name: Letairis
|Placebo Comparator: 2||
Other Name: The placebo will look identical to the Ambrisentan tablets
- Change in Pulmonary Vascular Resistance (Wood Units) [ Time Frame: 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) [ Time Frame: 4 months ]Freedom from clinically significant adverse events will be measure by determining the number free from CSAEs and those who developed CSAEs
- Change in 6 Minute Walk Distance [ Time Frame: Baseline and Four months ]subjects complete the 6 minute walk test to determine how far (in meters) they are able to walk in 6 minutes.
- Change in Functional Class [ Time Frame: basline and 4 months ]Change in functional class from baseline to month 4. This is graded from WHO FC I to FC IV. Assessment will be completed by an investigator on the study at every visit.
- Change in Short Form-36 Physical Functioning [ Time Frame: baseline 4 months ]Change between baseline and follow-up in the physical functioning items of the SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840463
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390-8550|
|Principal Investigator:||Kelly M Chin, MD||UT Southwestern Medical Center|
|Principal Investigator:||Fernando Torres, MD||UT Southwestern Medical Center|