A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Diastolic Heart Failure

In brief

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%.

Key facts

Study ID

NCT00303498

Run by

Pfizer

People needed

200

Starts

2006-03-27

Expected to finish

2008-05-01

Last updated by the study team

2023-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mid Carolina Cardiology — Huntersville, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Oklahoma Foundation for Cardiovascular Research — Oklahoma City, Oklahoma, United States
• The Oregon Clinic — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Advanced Heart Failure & Transplant Center — Philadelphia, Pennsylvania, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• RHJ VA Medical Center — Charleston, South Carolina, United States
• Black Hills Clinical Research Center — Rapid City, South Dakota, 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
• Intermountain Medical Center (a.k.a. LDS Hospital) — Murray, Utah, United States
• University of Utah — Salt Lake City, Utah, United States
• Fletcher Allen Health Care — Burlington, Vermont, United States
• Medical College of Virginia — Richmond, Virginia, United States
• University of Wisconsin Hospital & Clinics — Madison, Wisconsin, United States
• St Michael's Hospital — Toronto, Ontario, Canada
• SMBD Jewish General Hospital — Montreal, Quebec, Canada
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mobile Heart Specialists, PC — Mobile, Alabama, United States
• Mid Carolina Cardiology — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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