Diastolic Heart Failure Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study of Ranolazine in Patients With Heart Failure With Preserved Ejection Fraction
Patients with CAD and clinical symptoms of heart failure or patients with suspected heart failure with preserved ejection fraction (HFpEF) will be enrolled. Study drug will be given as continuous IV infusion followed by oral treatment for 13 days. LV pressures and hemodynamic data will be measured prior to and after administration of study drug. In addition, Doppler ECHO, cardiopulmonary exercise testing (CPET), and NT-pro-BNP determination will be performed. Adverse events and safety labs will be collected and monitored.
This is a randomized, double-blind, placebo-controlled proof-of-concept study of ranolazine
in patients with heart failure with preserved ejection fraction (HFpEF). Patients will be
randomized to receive ranolazine or placebo in a 1.5:1 ratio (12 ranolazine: 8 placebo).
Treatment will consist of intravenous infusion of study drug followed by oral treatment for
a total of 14 days treatment period. Study contact will be made approximately 14 days after
the treatment period to assess safety.
Cardiac catheterization will be performed for LV pressures and hemodynamic measurements
before and after drug administration. Doppler ECHO, CPET, and NT-pro-BNP determination will
be performed at screening and at end of study. Adverse events and safety labs will be
monitored and collected.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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