Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction
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.
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.
Currently, ranolazine carries FDA approval for the treatment of chronic angina only. We
intend to study ranolazine in patients with HFPEF, in the absence of documented ischemia, to
determine whether the drug's lusitropic properties can improve exercise capacity in HFPEF
patients.
Previous trials of ranolazine in patients with chronic angina found that there was a
dose-dependent relationship between improvements in exercise capacity and ranolazine.
However, there did appear to be a plateau in which 1500 mg of ranolazine twice daily improved
exercise capacity only slightly more than 1000 mg of ranolazine given twice daily.
Additionally, there was a substantially higher rate of adverse events (mainly nausea,
dizziness, and asthenia) with the higher dose. Given the desire to maximize benefit and
minimize the risk of adverse events, ranolazine 1000 mg by mouth twice daily was chosen as
the target dose.
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.
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