NCT01163734

Ranolazine in Diastolic Heart Failure

A Randomized, Double-blind, Placebo-controlled Study of Ranolazine in Patients With Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diastolic Heart Failure

Interventions

Type	Name	Description
DRUG	Ranolazine	Intravenous treatment followed oral treatment for 13 days.
OTHER	Saline 0.9% and placebo tablet	Intravenous treatment followed by oral treatment for 13 days

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-07-16
• Last updated: 2012-07-12

Locations

1 site across 1 country: Germany