Ranolazine in Diastolic Heart Failure (RALI-DHF)
|Diastolic Heart Failure||Drug: Ranolazine Other: Saline 0.9% and placebo tablet||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study of Ranolazine in Patients With Heart Failure With Preserved Ejection Fraction|
- Change from baseline to 30 minutes in cardiac catheterization hemodynamic parameters at both resting and paced conditions [ Time Frame: Baseline to 30 minutes ]
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)
- 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 ]
|Study Start Date:||April 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Intravenous treatment followed oral treatment for 13 days.
Other Name: Ranexa
Placebo Comparator: Saline 0.9%
Saline 0.9% and placebo tablet
Other: Saline 0.9% and placebo tablet
Intravenous treatment followed by oral treatment for 13 days
Other Name: Normal Saline
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163734
|University Medicine Goettingen (UMG)|
|Principal Investigator:||Lars S. Maier, MD||University Medicine Göttingen, Cardiac Center|