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Diastolic Heart FailurePhase 2NCT00303498

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

A Phase 2 study testing Sitexsentin sodium in people with Diastolic Heart Failure, run by Pfizer at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diastolic Heart Failure
What is being tested?
Sitexsentin sodium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
52 sitesin 2 countries
Study dates
27 Mar 2006to 1 May 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States50 sites

  • Cardiovascular Consultants of Maine

    Auburn, Maine, 04210

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital Pulmonary and Critical Care Unit

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Buffalo Cardipul Assoc

    Buffalo, New York, 14221-5838

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • RHJ VA Medical Center

    Charleston, South Carolina, 29401

  • Mid Carolina Cardiology

    Charlotte, North Carolina, 28204-3288

  • The University of Chicago

    Chicago, Illinois, 60637

  • The Ohio State University

    Columbus, Ohio, 43210-1252

  • Stern Cardiovascular Center

    Germantown, Tennessee, 38138

  • Baylor College of Medicine Pulmonary Section

    Houston, Texas, 77030

  • Kelsey Seybold Clinic

    Houston, Texas, 77030

  • Methodist DeBakey Heart Center

    Houston, Texas, 77030

  • Mid Carolina Cardiology

    Huntersville, North Carolina, 28078

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Central Arkansas Veterans HCS

    Little Rock, Alaska, 72205

  • University of Arkansas for Medical Services/Cardiology Department

    Little Rock, Arkansas, 72205

  • University of Southern California Medical Center

    Los Angeles, California, 90033

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53792

  • Catholic Medical Center d/b/a New England Heart Institute

    Manchester, New Hampshire, 03102

  • VA Med Ctr Minneapolis

    Minneapolis, Minnesota, 55417-2309

  • Mobile Heart Specialists, PC

    Mobile, Alabama, 36608

  • Preventative and Research Cardiloogy Providence Hospital

    Mobile, Alabama, 36608

  • Intermountain Medical Center (a.k.a. LDS Hospital)

    Murray, Utah, 84157

  • Yale University School of Medicine, Cardiovascular Medicine

    New Haven, Connecticut, 06510

  • Columbia University Medical Center, New York Presbyterian Hospital

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73120

  • Orange County Heart Institute and Research Center

    Orange, California, 92868

  • Florida Heart Group Pa

    Orlando, Florida, 32803

  • Methodist Medical Center

    Peoria, Illinois, 61606

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Advanced Heart Failure & Transplant Center

    Philadelphia, Pennsylvania, 19140

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Arizona Pulmonary Specialists, LTD

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Black Hills Clinical Research Center

    Rapid City, South Dakota, 57701

  • Medical College of Virginia

    Richmond, Virginia, 23298

  • Sacramento Heart & Vascular Medical Associates

    Sacramento, California, 95825

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California

    San Diego, California, 92103-8411

  • St. Louis University Hospital

    St Louis, Missouri, 63110

  • Washington Univ. School of Medicine

    St Louis, Missouri, 63110

  • Capital Cardiology Associates

    Troy, New York, 112180

  • Parkview Research Center

    Tucson, Arizona, 85715

  • Southwest Heart

    Tucson, Arizona, 85715

  • Capital City Research, CCRW

    Washington D.C., District of Columbia, 20011

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157-1045

Other trials in United States

Canada2 sites

  • SMBD Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St Michael's Hospital

    Toronto, Ontario, M5B1W8

Other trials in Canada

About this study

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

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%.

Being tested
Sitexsentin sodium, Placebo
Medical subject headings
Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sitexsentin sodiumDrug

    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

  • PlaceboDrug

    placebo identical to the study drug in description, dose and duration

Study groups in NCT00303498
Study groupRoleWhat they receive
Sitaxsentan sodiumExperimentalNot described
Receives: Drug: Sitexsentin sodium
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 24 (Maintenance Phase)

Secondary outcomes (6)

  1. 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).

    Measured: Baseline, Week 24 (Maintenance Phase)

  2. 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.

    Measured: Baseline, Week 24 (Maintenance Phase)

  3. 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.

    Measured: Baseline, Week 24 (Maintenance Phase)

  4. 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.

    Measured: Baseline, Week 24 (Maintenance Phase)

  5. 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.

    Measured: Baseline, Week M24 (Maintenance Phase)

  6. 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).

    Measured: Baseline, Week 24 (Maintenance Phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study start27 Mar 2006
  3. Primary completion1 May 2008
  4. Study completion1 May 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303498
Sponsor's protocol ID
B1321006
Other IDs
FDHF01
Status last verified
Dec 2022
First submitted
16 Mar 2006
Last updated
4 Jan 2023
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 24720918

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitexsentin sodium in people with Diastolic Heart Failure, run by Pfizer at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Treadmill Exercise Time at Maintenance Phase Week 24 (time frame: Baseline, Week 24 (Maintenance Phase)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303498, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.

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