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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00303498
Other study ID # B1321006
Secondary ID FDHF01
Status Completed
Phase Phase 2
First received
Last updated
Start date March 27, 2006
Est. completion date May 1, 2008

Study information

Verified date December 2022
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 1, 2008
Est. primary completion date May 1, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Intervention

Drug:
Sitexsentin sodium
sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months
Placebo
placebo identical to the study drug in description, dose and duration

Locations

Country Name City State
Canada SMBD Jewish General Hospital Montreal Quebec
Canada St Michael's Hospital Toronto Ontario
United States Cardiovascular Consultants of Maine Auburn Maine
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Pulmonary and Critical Care Unit Boston Massachusetts
United States Buffalo Cardipul Assoc Buffalo New York
United States Fletcher Allen Health Care Burlington Vermont
United States RHJ VA Medical Center Charleston South Carolina
United States Mid Carolina Cardiology Charlotte North Carolina
United States The University of Chicago Chicago Illinois
United States The Ohio State University Columbus Ohio
United States Stern Cardiovascular Center Germantown Tennessee
United States Baylor College of Medicine Pulmonary Section Houston Texas
United States Kelsey Seybold Clinic Houston Texas
United States Methodist DeBakey Heart Center Houston Texas
United States Mid Carolina Cardiology Huntersville North Carolina
United States Nebraska Heart Institute Lincoln Nebraska
United States Central Arkansas Veterans HCS Little Rock Alaska
United States University of Arkansas for Medical Services/Cardiology Department Little Rock Arkansas
United States University of Southern California Medical Center Los Angeles California
United States University of Wisconsin Hospital & Clinics Madison Wisconsin
United States Catholic Medical Center d/b/a New England Heart Institute Manchester New Hampshire
United States VA Med Ctr Minneapolis Minneapolis Minnesota
United States Mobile Heart Specialists, PC Mobile Alabama
United States Preventative and Research Cardiloogy Providence Hospital Mobile Alabama
United States Intermountain Medical Center (a.k.a. LDS Hospital) Murray Utah
United States Yale University School of Medicine, Cardiovascular Medicine New Haven Connecticut
United States Columbia University Medical Center, New York Presbyterian Hospital New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Oklahoma Foundation for Cardiovascular Research Oklahoma City Oklahoma
United States Orange County Heart Institute and Research Center Orange California
United States Florida Heart Group Pa Orlando Florida
United States Methodist Medical Center Peoria Illinois
United States Advanced Heart Failure & Transplant Center Philadelphia Pennsylvania
United States Albert Einstein Medical Center Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Pulmonary Specialists, LTD Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States The Oregon Clinic Portland Oregon
United States Black Hills Clinical Research Center Rapid City South Dakota
United States Medical College of Virginia Richmond Virginia
United States Sacramento Heart & Vascular Medical Associates Sacramento California
United States St. Louis University Hospital Saint Louis Missouri
United States Washington Univ. School of Medicine Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States University of California San Diego California
United States Capital Cardiology Associates Troy New York
United States Parkview Research Center Tucson Arizona
United States Southwest Heart Tucson Arizona
United States Capital City Research, CCRW Washington District of Columbia
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Treadmill Exercise Time at Maintenance Phase Week 24 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. Baseline, Week 24 (Maintenance Phase)
Secondary Change From Baseline in Ratio of Transmitral Inflow Velocity (E) to Early Diastolic Velocity of the Mitral Annulus (E') at Maintenance Phase Week 24 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). Baseline, Week 24 (Maintenance Phase)
Secondary Change From Baseline in Left Ventricular Mass at Maintenance Phase Week 24 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. Baseline, Week 24 (Maintenance Phase)
Secondary Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Total Score at Maintenance Phase Week 24 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. Baseline, Week 24 (Maintenance Phase)
Secondary Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Physical Score at Maintenance Phase Week 24 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. Baseline, Week 24 (Maintenance Phase)
Secondary Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Emotional Score at Maintenance Phase Week 24 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. Baseline, Week M24 (Maintenance Phase)
Secondary Number of Participants With Change From Baseline in New York Heart Association (NYHA) Functional Class at Maintenance Phase Week 24 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). Baseline, Week 24 (Maintenance Phase)
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