The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction (RAZE)
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Purpose
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.
| Condition | Intervention |
|---|---|
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Heart Failure With Preserved Ejection Fraction |
Drug: Ranolazine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction |
- Change in Exercise Capacity from Baseline at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]The primary endpoint for this study is the change in exercise capacity measured primarily by a treadmill test, but also by a six minute walk and oxygen uptake under stress.
- Echocardiographic Changes from Baseline at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]In order to determine any change in cardiac function, echocardiograms will be performed at baseling and the termination of the study drug.
- Change in Quality of Life [ Time Frame: Baseline, 6-weeks, 8-weeks ] [ Designated as safety issue: No ]Questionnaires will be administered to assess quality of life prior and post treatment. These questionnaires are the Minnesota Living with Heart Failure Questiannaire and the Kansas City Cardiomyopathy Questionnaire.
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ranolazine
Patients with be given 500 mg by mouth twice a day for three days, and then the dose will be increased to 1000 mg by mouth twice daily thereafter. (patients who concurrently take moderate CYP3A inhibitors including diltiazem, verapamil, aprepitant, erythromycin, and fluconazole will continue to 500 mg by mouth twice a day for the entire dosing period)
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Drug: Ranolazine
Patients with be given 500 mg by mouth twice a day for three days, and then the dose will be increased to 1000 mg by mouth twice daily thereafter. (patients who concurrently take moderate CYP3A inhibitors including diltiazem, verapamil, aprepitant, erythromycin, and fluconazole will continue to 500 mg by mouth twice a day for the entire dosing period)
Other Names:
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Placebo Comparator: Placebo
Patients will be given 1 tab twice a day for 3 days, then increasing to 2 tabs twice a day thereafter (patients who concurrently take moderate CYP3A inhibitors, will be given 1 tab twice daily for the entire dosing period)
|
Drug: Placebo
Patients will be given 1 tab twice a day for 3 days, then increasing to 2 tabs twice a day thereafter (patients who concurrently take moderate CYP3A inhibitors, will be given 1 tab twice daily for the entire dosing period)
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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 failure with preserved ejection fraction is a condition where the heart squeezes well but is stiff. This stiffness in the heart muscle makes the heart unable to fill, leading to shortness of breath and decreased exercise tolerance. Subjects with HFPEF are asked to participate in this study. There will be approximately 40 participants enrolled in this study. The purpose of this study is to investigate the effects of Ranolazine (Ranexa) in patients with HFPEF. The study is sponsored by the manufacturers of the drug, Gilead Pharmaceuticals.
Ranolazine is a drug that affects the ion channels in the heart. In patients with heart failure, these ion channels do not work properly, and contribute to make the heart stiff. A stiff heart leads to the symptoms of shortness of breath which patients with HFPEF experience. Due to its properties, Ranolazine may improve this stiffness. Ranolazine could improve subject's shortness of breath and ability to exercise.
Ranolazine is approved for patients who suffer from chest pain and has been shown to help these patients be able to exercise longer and have less chest pain. Ranolazine has not been approved for improvement in exercise in patients with HFPEF. The investigators hope to study whether Ranolazine can help patients with HFPEF in this study.
To properly evaluate the effects of Ranolazine, this research study is set up as a double blind, placebo controlled study. Subjects will be randomly assigned (like rolling a dice) to either Ranolazine or placebo (inactive substance). Subjects will have a 50% chance of getting the study drug and 50% chance of getting placebo.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
I. Inclusion Criteria
- Age > 18 years old
Diagnosis of HFPEF:
- Signs or symptoms of heart failure (breathlessness, pulmonary congestion, edema, fatigue), NYHA Class II-III CHF AND
- LVEF > 45% AND
Evidence of elevated LV filling pressures
- E/E'mitral > 8
- BNP > 80 pg/mL
- PA systolic pressure > 35 mm Hg on echocardiography
- Stable medical management for at least 1 month
II. Exclusion Criteria
- Inability to perform 6 minute walk 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 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
- QTc > 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 CYP3A (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
- Current treatment with CYP3A and P-GP 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.
Contacts and Locations| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92037 | |
| Principal Investigator: | Denise D Barnard, MD | University of California, San Diego |
More Information
No publications provided
| Responsible Party: | Denise Barnard, Clinical Professor of Medicine, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01505179 History of Changes |
| Other Study ID Numbers: | IN-US-259-0109, 110344 |
| Study First Received: | December 8, 2011 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
HFPEF Heart Failure HF w/ preserved EF |
Preserved EF Preserved Ejection Fraction Diastolic Dysfunction |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Ranolazine |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013