Heart Failure With Preserved Ejection Fraction Clinical Trial
— RAZEOfficial title:
The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction
Verified date | January 2020 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Gilead Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Exercise Capacity at 6 Weeks | Exercise capacity in terms of exercise duration (time in seconds) as described for the baseline value, is repeated at 6 weeks. | 6 weeks | |
Primary | Change in Oxygen Consumption (VO2) at 6 Weeks | Oxygen consumption (VO2) as described at baseline is remeasured after 6 weeks of drug vs placebo. | 6 weeks | |
Secondary | Change in Quality of Life (QOL) Score | The Minnesota Living with Heart Failure (HF) Questionnaire was re-administered at the 6 week time point. The total quality of life (QOL) scores were compared to the baseline score. The well-validated Minnesota Living with Heart Failure questionnaire is self-administered, has 21 questions and takes 5-10 minutes to complete. The test measures perceived health-related QOL. Each question is scored from 0 to 5 on the Likert scale, where 0 is 'none', and 5 is 'very much'. QOL scores range from 0 to 105; a lower score represents a better quality of life. After an intervention, a decrease in score reflects an improvement in QOL. A minimally important difference in the total score is 5 points. | 6 weeks | |
Secondary | Change in Doppler Echocardiographic Parameters, Septal E/e' Ratio (E/e') | Doppler echo allows non-invasive evaluation of diastolic cardiac function. The mitral inflow velocity (E) correlates with LV filling pressure, but is influenced by myocardial relaxation time (RT) and filling pressure. The early diastolic septal mitral annular tissue velocity (e') varies with RT alone. The unitless ratio of the E to e' velocities (E/e') is considered a reliable surrogate of LV filling pressure. Prediction of normal diastolic filling pressure is most reliable when E/e' is < 8; and of abnormal filling pressure when E/e' is > 15. The percent change is reported. | 6 weeks |
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