Status:
COMPLETED
The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Gilead Sciences
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Denise Barnard, M.D., and her associates, are conducting a research study to find out more about ways to improve symptoms in patients with Heart Failure with Preserved Ejection Fraction (HFPEF). Heart...
Eligibility Criteria
Inclusion
- 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
- E/e-prime (E/e') mitral ratio \> 8. Mitral E/e' ratio has been proposed as a noninvasive measure of left ventricular filling pressure.
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01505179
Start Date
February 1 2011
End Date
January 1 2015
Last Update
January 18 2020
Active Locations (1)
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1
University of California, San Diego
San Diego, California, United States, 92037