The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether treatment with Ranolazine will improve exercise capacity in patients with Heart Failure with preserved left ventricular ejection fraction, or HFPEF.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: Gilead Sciences
• Treatments: Cytochrome P-450 CYP3A Inhibitors; Ranolazine

Criteria

I. Inclusion Criteria

• Age > 18 years old

• Diagnosis of Heart Failure (HF) with Preserved Ejection Fraction (PEF)

• Signs or symptoms of heart failure (breathlessness, pulmonary congestion, edema, fatigue), NYHA (New York Heart Association) Class II-III HF AND

• LVEF (Left Ventricular Ejection Fraction) > 45% AND

• Evidence of elevated LV filling pressures

1. E/e-prime (E/e') mitral ratio > 8. Mitral E/e' ratio has been proposed as a noninvasive measure of left ventricular filling pressure.

2. Brain natiuretic peptide (BNP) > 80 pg/mL. BNP is biomarker of ventricular wall stress.

• Pulmonary Artery systolic pressure estimated at > 35 mm Hg on echocardiography

• Stable medical management for at least 1 month

II. Exclusion Criteria

• Inability to perform 6 minute walk (6MW) test or 6 minute walk distance > 550 meters at baseline

• Inability to perform the Naughton protocol exercise test, or an absolute contraindication to exercise testing

• Decompensated heart failure

• Clinically significant valvular disease or congenital cardiac defects

• Clinical diagnosis of Chronic obstructive pulmonary disease (COPD) or significant lung pathology

• Prior treatment with ranolazine

• Percutaneous coronary intervention within the past 6 months or planned intervention during the study period

• Acute coronary syndrome within the prior 2 months

• Presence of uncorrected perfusion defects on stress testing

• Presence of angina

• Any rhythm other than sinus

• Electrocardiogram measured QTc interval > 500 msec

• Clinically significant hepatic impairment (ALT/AST > 3x upper limit of normal)

• Participation in another investigational drug or device study within 1 month prior to screening

• Females of childbearing potential

• Current treatment with potent inhibitors of hepatic cytochrome P450 (CYP) enzyme complex pathways affecting drug metabolism (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)

• Current treatment with CYP3A and/or P-Glycoprotein (Pgp) inducers (e.g. rifampin, rifampicin, carbamazepine, St. John's wort)

• Any other conditions that in the opinion of the investigators are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study.