Exploratory Efficacy Study of Sitaxsentan Sodium to Improve Impaired Exercise Tolerance in Subjects with Diastolic Heart Failure

Study Description

The study was designed to determine the effects of the administration of sitaxsentan in the treatment of diastolic heart failure (HF) (characterized by chronic HF with a normal left ventricular ejection fraction) after a 10-week dose escalation (25 mg to target dose of 100 mg).

Contact Information

Status:

Name, Phone, Email:
Kirk Volkman, NP
Jerri Housley, Research Coordinator
801-585-5122
Kirk.volkman@hsc.utah.edu
Jerri.housely@hsc.utah.edu

Principle Investigator:
Edward Michael Gilbert, M.D.

Please Note:

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Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.

Participant Eligibility

Inclusion Criteria:

Age Range: 18 years or greater
Left ventricular ejection fraction (LVEF) = 50%.
The subject has ECHO evidence of concentric remodeling and/or diastolic dysfunction as indicated by 1 or more of the following:
a. Left ventricular mass = 125 g/m2 ;
b. Left atrial diameter = 4.5 cm.
c. Wall thickness of = 11 mm;
d. Relative wall thickness of 2 times wall thickness ÷ radius being = 0.45 mm;
e. Tissue Doppler imaging of the mitral annulus (E') = 8 cm/sec.

Exclusion Criteria:

The subject has liver disease and/or elevated liver enzymes defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 1.5 times the upper limit of normal of the normal range at any time during the Screening procedures.
The subject has anemia defined as a hemoglobin concentration (Hgb) below 10.0 g/dL.
The subject has uncontrolled systemic hypertension defined as a blood pressure of = 140/90 mmHg if on no treatment for systemic hypertension, or a blood pressure = 160/90 mmHg if on = 2 systemic hypertension medications or if treated for diabetes < 130/80.
The subject has chronic renal impairment or renal insufficiency defined by a serum creatinine = 2.5 mg/dL and/or requires dialysis.
The subject is taking warfarin, or warfarin analogue, anticoagulation therapy.
The subject is taking cyclosporine or glyburide.
The subject has amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.

How long does the study run?

Until 150 subjects are enrolled nationwide

Location(s) of the Clinical Trial

University of Utah Health Sciences Outpatient Clinic #10

Clinical Trials