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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diastolic Heart Failure

Treatments: Drug: Placebo; Drug: Sitexsentin sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00303498

B1321006

FDHF01

Details and patient eligibility

About

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%.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Sitaxsentan sodium

Experimental group

Treatment:

Drug: Sitexsentin sodium

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo