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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
20
Intravenous treatment followed oral treatment for 13 days.
Intravenous treatment followed by oral treatment for 13 days
University Medicine Goettingen (UMG)
Göttingen, Germany
Change from baseline to 30 minutes in cardiac catheterization hemodynamic parameters at both resting and paced conditions
Change from baseline to 30 minutes from initiation of study drug bolus No.1 in cardiac catheterization hemodynamic parameters at both resting and paced conditions: Time-constant of relaxation (tau) Left ventricular end-diastolic pressure (LVEDP) dP/dtmin (minimal rate of LV pressure change)
Time frame: Baseline to 30 minutes
Change from baseline to Day 14 in mitral E wave velocity/mitral annular velocity (E/E') ratio
Time frame: Baseline to Day 14
Change from baseline to Day 14 in VO2 max
Time frame: Baseline to Day 14
Change from baseline to Day 14 in N-terminal pro-brain B-type natriuretic peptide (NT-pro-BNP)
Time frame: Baseline to Day 14
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