Clinical trial NCT00303498: A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
Official title: A PHASE 2 RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED EXPLORATORY EFFICACY STUDY OF SITAXSENTAN SODIUM TO IMPROVE IMPAIRED EXERCISE TOLERANCE IN SUBJECTS WITH DIASTOLIC HEART FAILURE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diastolic Heart Failure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Treadmill Exercise Time at Maintenance Phase Week 24
timeFrame: Baseline, Week 24 (Maintenance Phase)
Secondary outcomes:
measure: Change From Baseline in Ratio of Transmitral Inflow Velocity (E) to Early Diastolic Velocity of the Mitral Annulus (E') at Maintenance Phase Week 24
timeFrame: Baseline, Week 24 (Maintenance Phase)
measure: Change From Baseline in Left Ventricular Mass at Maintenance Phase Week 24
timeFrame: Baseline, Week 24 (Maintenance Phase)
measure: Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Total Score at Maintenance Phase Week 24
timeFrame: Baseline, Week 24 (Maintenance Phase)
measure: Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Physical Score at Maintenance Phase Week 24
timeFrame: Baseline, Week 24 (Maintenance Phase)
measure: Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Emotional Score at Maintenance Phase Week 24
timeFrame: Baseline, Week M24 (Maintenance Phase)
measure: Number of Participants With Change From Baseline in New York Heart Association (NYHA) Functional Class at Maintenance Phase Week 24
timeFrame: Baseline, Week 24 (Maintenance Phase)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Mobile Heart Specialists, PC
state: Alabama
city: Mobile
country: United States
facility: Preventative and Research Cardiloogy Providence Hospital
state: Alabama
city: Little Rock
country: United States
facility: Central Arkansas Veterans HCS
state: Alaska
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, LTD
state: Arizona
city: Tucson
country: United States
facility: Parkview Research Center
state: Arizona
city: Tucson
country: United States
facility: Southwest Heart
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Services/Cardiology Department
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California Medical Center
state: California
city: Orange
country: United States
facility: Orange County Heart Institute and Research Center
state: California
city: Sacramento
country: United States
facility: Sacramento Heart & Vascular Medical Associates
state: California
city: San Diego
country: United States
facility: University of California
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine, Cardiovascular Medicine
state: Connecticut
city: Washington
country: United States
facility: Capital City Research, CCRW
state: District of Columbia
city: Orlando
country: United States
facility: Florida Heart Group Pa
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center
state: Illinois
city: Auburn
country: United States
facility: Cardiovascular Consultants of Maine
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital Pulmonary and Critical Care Unit
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: VA Med Ctr Minneapolis
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington Univ. School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Manchester
country: United States
facility: Catholic Medical Center d/b/a New England Heart Institute
state: New Hampshire
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo Cardipul Assoc
state: New York
city: New York
country: United States
facility: Columbia University Medical Center, New York Presbyterian Hospital
state: New York
city: Troy
country: United States
facility: Capital Cardiology Associates
state: New York
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Huntersville
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Advanced Heart Failure & Transplant Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: RHJ VA Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Clinical Research Center
state: South Dakota
city: Germantown
country: United States
facility: Stern Cardiovascular Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine Pulmonary Section
state: Texas
city: Houston
country: United States
facility: Kelsey Seybold Clinic
state: Texas
city: Houston
country: United States
facility: Methodist DeBakey Heart Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center (a.k.a. LDS Hospital)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zile MR, Bourge RC, Redfield MM, Zhou D, Baicu CF, Little WC. Randomized, double-blind, placebo-controlled study of sitaxsentan to improve impaired exercise tolerance in patients with heart failure and a preserved ejection fraction. JACC Heart Fail. 2014 Apr;2(2):123-30. doi: 10.1016/j.jchf.2013.12.002. Epub 2014 Feb 26.