A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
- Conditions
- Diastolic Heart Failure
- Interventions
- Drug: PlaceboDrug: Sitexsentin sodium
- Registration Number
- NCT00303498
- Lead Sponsor
- Pfizer
- Brief Summary
The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 18 or older with chronic heart failure and evidence of diastolic dysfunction on echocardiogram, heart imaging, and a minimum exercise tolerance average time of 120 seconds on two treadmill tests within 2 weeks of enrollment
- unstable cardiovascular disease within 4 weeks of screening, history of heart attack, cardiac by-pass surgery or percutaneous intervention, stent placement, within 3 months of screening or amyloidosis, hypertrophic obstructive or restrictive cardiomyopathy, or constrictive pericarditis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Sitaxsentan sodium Sitexsentin sodium -
- Primary Outcome Measures
Name Time Method Change From Baseline in Treadmill Exercise Time at Maintenance Phase Week 24 Baseline, Week 24 (Maintenance Phase) Treadmill exercise test is used to assess the functional capacity of participants with cardiac disease. Treadmill exercise test was conducted using the 2 minute incremental Naughton protocol. The Naughton protocol starts with a 2 minute warm-up. The speed of treadmill is set to 1 mile per hour (mph) and the incline is set to 0. After the warm-up, the speed is set at 2 mph for the remainder of the test. The test consists of six, 2 minute intervals. The grade starts at 0 for the first interval, and increases by 3.5 percent every 2 minutes. The change in total exercise time (in seconds) during the treadmill test was reported.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Physical Score at Maintenance Phase Week 24 Baseline, Week 24 (Maintenance Phase) The MLHF is a 21-item questionnaire which is used to evaluate QoL in participants suffering from heart failure. The participants were asked to evaluate how their heart condition affected their life during the past month. Each of the 21 items were assessed on a 6-point scale, where 0 = no affect and 5 = very much affected. The MLHF QoL physical score was calculated as the sum of the 8 physical domain QoL questions. The MLHF QoL physical score ranged from 0 to 40, where higher scores indicated worse health condition.
Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Total Score at Maintenance Phase Week 24 Baseline, Week 24 (Maintenance Phase) The MLHF is a 21-item questionnaire which used to evaluate QoL in participants suffering from heart failure. The participants were asked to evaluate how their heart condition affected their life during the past month. Each of the 21 items were assessed on a 6-point scale, where 0 = no affect and 5 = very much affected. The MLHF QoL total score was calculated as the sum of the 21 individual QoL questions. The MLHF QoL total score ranged from 0 to 105, where higher scores indicated worse health condition.
Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Emotional Score at Maintenance Phase Week 24 Baseline, Week M24 (Maintenance Phase) The MLHF is a 21-item questionnaire which is used to evaluate QoL in participants suffering from heart failure. The participants were asked to evaluate how their heart condition affected their life during the past month. Each of the 21 items were assessed on a 6-point scale, where 0 = no affect and 5 = very much affected. The MLHF QoL emotional score was calculated as the sum of the 5 emotional domain QoL questions. The MLHF QoL emotional score ranged from 0 to 25, where higher scores indicated worse health condition.
Change From Baseline in Left Ventricular Mass at Maintenance Phase Week 24 Baseline, Week 24 (Maintenance Phase) Left ventricular mass was used as a parameter for the assessment of cardiac function. An increase in left ventricular mass leads to ventricular hypertrophy which is a prognostic factor of cardiovascular morbidity and mortality. Left ventricular mass was measured by ECHO, which was calculated as (1.04 \* \[{left ventricular end diastolic diameter (LVEDD) + septal diastolic thickness + post wall diastolic thickness}\^3 - LVEDD\^3\]) \* 0.8 + 0.6. Left ventricular mass was assessed for the two ECHO modes: parasternal long-axis two dimensional (PLAX 2D) mode and parasternal short-axis view motion (PSAX M) mode.
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Functional Class at Maintenance Phase Week 24 Baseline, Week 24 (Maintenance Phase) Participants were classified by NYHA functional class. NYHA class I: participants with cardiac disease but without resulting limitations of physical activity, NYHA class II: participants with cardiac disease resulting in slight limitation of physical activity, NYHA class III: participants with cardiac disease resulting in marked limitation of physical activity, NYHA class IV: participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. Baseline was reported by NYHA functional class and the change from baseline in the functional class was reported as improvement (positive change from baseline), no change and deterioration (negative change from baseline).
Change From Baseline in Ratio of Transmitral Inflow Velocity (E) to Early Diastolic Velocity of the Mitral Annulus (E') at Maintenance Phase Week 24 Baseline, Week 24 (Maintenance Phase) Ratio of E to E' is used as a predictor of first cardiac events. Ratio of E to E' was measured using imaging techniques based on Doppler principles. Transmitral inflow velocity was measured by Doppler echocardiography (ECHO) and the early diastolic velocity of the mitral annulus was measured by tissue Doppler imaging (TDI).
Trial Locations
- Locations (51)
Massachusetts General Hospital Pulmonary and Critical Care Unit
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Baylor College of Medicine Pulmonary Section
🇺🇸Houston, Texas, United States
Kelsey Seybold Clinic
🇺🇸Houston, Texas, United States
Parkview Research Center
🇺🇸Tucson, Arizona, United States
Central Arkansas Veterans HCS
🇺🇸Little Rock, Alaska, United States
Cardiovascular Consultants of Maine
🇺🇸Auburn, Maine, United States
Catholic Medical Center d/b/a New England Heart Institute
🇺🇸Manchester, New Hampshire, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
University of Arkansas for Medical Services/Cardiology Department
🇺🇸Little Rock, Arkansas, United States
University of California
🇺🇸San Diego, California, United States
VA Med Ctr Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Yale University School of Medicine, Cardiovascular Medicine
🇺🇸New Haven, Connecticut, United States
Florida Heart Group Pa
🇺🇸Orlando, Florida, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Arizona Pulmonary Specialists, LTD
🇺🇸Phoenix, Arizona, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸Oklahoma City, Oklahoma, United States
Mobile Heart Specialists, PC
🇺🇸Mobile, Alabama, United States
Preventative and Research Cardiloogy Providence Hospital
🇺🇸Mobile, Alabama, United States
Southwest Heart
🇺🇸Tucson, Arizona, United States
University of Southern California Medical Center
🇺🇸Los Angeles, California, United States
Orange County Heart Institute and Research Center
🇺🇸Orange, California, United States
Sacramento Heart & Vascular Medical Associates
🇺🇸Sacramento, California, United States
Capital City Research, CCRW
🇺🇸Washington, District of Columbia, United States
Methodist Medical Center
🇺🇸Peoria, Illinois, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Washington Univ. School of Medicine
🇺🇸Saint Louis, Missouri, United States
St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Buffalo Cardipul Assoc
🇺🇸Buffalo, New York, United States
Columbia University Medical Center, New York Presbyterian Hospital
🇺🇸New York, New York, United States
Capital Cardiology Associates
🇺🇸Troy, New York, United States
Mid Carolina Cardiology
🇺🇸Huntersville, North Carolina, United States
RHJ VA Medical Center
🇺🇸Charleston, South Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Advanced Heart Failure & Transplant Center
🇺🇸Philadelphia, Pennsylvania, United States
Stern Cardiovascular Center
🇺🇸Germantown, Tennessee, United States
Black Hills Clinical Research Center
🇺🇸Rapid City, South Dakota, United States
Intermountain Medical Center (a.k.a. LDS Hospital)
🇺🇸Murray, Utah, United States
Methodist DeBakey Heart Center
🇺🇸Houston, Texas, United States
Medical College of Virginia
🇺🇸Richmond, Virginia, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
SMBD Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
University of Wisconsin Hospital & Clinics
🇺🇸Madison, Wisconsin, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States