Phase 2
N=192
A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
Diastolic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00303498 ↗Enrolled (actual)
192
Serious AEs
21.5%
Results posted
Jan 2023
Primary outcome: Primary: Change From Baseline in Treadmill Exercise Time at Maintenance Phase Week 24 — 424.5; 485.0; 89.5; 37.0 Seconds — p=0.0302
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sitexsentin sodium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Treadmill Exercise Time at Maintenance Phase Week 24 |
424.5; 485.0; 89.5; 37.0 | 0.0302 sig |
| 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 |
13.72; 14.45; -0.12; 0.38 | 0.4950 |
| SECONDARY Change From Baseline in Left Ventricular Mass at Maintenance Phase Week 24 |
217.73; 226.14; 229.88; 229.19; 3.09; -7.52 | 0.3874 |
| SECONDARY Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Total Score at Maintenance Phase Week 24 |
43.79; 37.67; -8.20; -6.31 | 0.8998 |
| SECONDARY Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Physical Score at Maintenance Phase Week 24 |
21.73; 18.85; -4.06; -2.35 | 0.7245 |
| SECONDARY Change From Baseline in Minnesota Living With Heart Failure (MLHF) Questionnaire - Quality of Life (QoL) Emotional Score at Maintenance Phase Week 24 |
8.97; 7.37; -1.87; -1.40 | 0.8649 |
| SECONDARY Number of Participants With Change From Baseline in New York Heart Association (NYHA) Functional Class at Maintenance Phase Week 24 |
58; 27; 38; 25; 30; 18 | 0.5909 |
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
Data sourced from ClinicalTrials.gov (NCT00303498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.