A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
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
2 other identifiers
interventional
200
2 countries
52
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2006
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2006
CompletedFirst Posted
Study publicly available on registry
March 17, 2006
CompletedStudy Start
First participant enrolled
March 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
January 4, 2023
CompletedJanuary 4, 2023
December 1, 2022
2.1 years
March 16, 2006
December 8, 2022
December 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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)
Change From Baseline in Left Ventricular Mass at Maintenance Phase Week 24
Baseline, Week 24 (Maintenance Phase)
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)
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)
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)
- +1 more secondary outcomes
Study Arms (2)
Sitaxsentan sodium
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (52)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mobile Heart Specialists, PC
Mobile, Alabama, 36608, United States
Preventative and Research Cardiloogy Providence Hospital
Mobile, Alabama, 36608, United States
Central Arkansas Veterans HCS
Little Rock, Alaska, 72205, United States
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, 85013, United States
Parkview Research Center
Tucson, Arizona, 85715, United States
Southwest Heart
Tucson, Arizona, 85715, United States
University of Arkansas for Medical Services/Cardiology Department
Little Rock, Arkansas, 72205, United States
University of Southern California Medical Center
Los Angeles, California, 90033, United States
Orange County Heart Institute and Research Center
Orange, California, 92868, United States
Sacramento Heart & Vascular Medical Associates
Sacramento, California, 95825, United States
University of California
San Diego, California, 92103-8411, United States
Yale University School of Medicine, Cardiovascular Medicine
New Haven, Connecticut, 06510, United States
Capital City Research, CCRW
Washington D.C., District of Columbia, 20011, United States
Florida Heart Group Pa
Orlando, Florida, 32803, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Methodist Medical Center
Peoria, Illinois, 61606, United States
Cardiovascular Consultants of Maine
Auburn, Maine, 04210, United States
Massachusetts General Hospital Pulmonary and Critical Care Unit
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
VA Med Ctr Minneapolis
Minneapolis, Minnesota, 55417-2309, United States
St. Louis University Hospital
St Louis, Missouri, 63110, United States
Washington Univ. School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Catholic Medical Center d/b/a New England Heart Institute
Manchester, New Hampshire, 03102, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Buffalo Cardipul Assoc
Buffalo, New York, 14221-5838, United States
Columbia University Medical Center, New York Presbyterian Hospital
New York, New York, 10032, United States
Capital Cardiology Associates
Troy, New York, 112180, United States
Mid Carolina Cardiology
Charlotte, North Carolina, 28204-3288, United States
Mid Carolina Cardiology
Huntersville, North Carolina, 28078, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-1045, United States
The Ohio State University
Columbus, Ohio, 43210-1252, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120, United States
The Oregon Clinic
Portland, Oregon, 97220, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Advanced Heart Failure & Transplant Center
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
RHJ VA Medical Center
Charleston, South Carolina, 29401, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, 57701, United States
Stern Cardiovascular Center
Germantown, Tennessee, 38138, United States
Baylor College of Medicine Pulmonary Section
Houston, Texas, 77030, United States
Kelsey Seybold Clinic
Houston, Texas, 77030, United States
Methodist DeBakey Heart Center
Houston, Texas, 77030, United States
Intermountain Medical Center (a.k.a. LDS Hospital)
Murray, Utah, 84157, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Medical College of Virginia
Richmond, Virginia, 23298, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792, United States
St Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Related Publications (1)
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.
PMID: 24720918DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2006
First Posted
March 17, 2006
Study Start
March 27, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
January 4, 2023
Results First Posted
January 4, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.