Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Not Applicable

Terminated

• Conditions: Echocardiography; Ranolazine; Diastolic Heart Failure; Tissue Doppler Ultrasound
• Interventions: Drug: ranolazine

• Registration Number: NCT00574756
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Moderate of severe diastolic dysfunction, E/Ea>12
• Preserved systolic function
• NYHA Class I-II

Exclusion Criteria

• QTc >450 msec at enrollment
• Taking medications that prolong QT interval or are potent inhibitors of CYP3A
• Significant coronary artery disease
• Severe valvular disease
• Hepatic disease
• Severe kidney disease
• Women of childbearing age
• Prior serious ventricular arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	ranolazine	Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks
1	ranolazine	Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in E/Ea	2 weeks

Secondary Outcome Measures

Name	Time	Method
changes in mitral inflow parameters (E, A, IVRT, DT)	2 weeks
Changes in pulmonary venous inflow (S, D, a reversal)	2 weeks
Changes in tissue doppler parameters (Ea, Aa)	2 weeks

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States