Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

University of California San Diego

Status: Terminated

Conditions: Diastolic Heart Failure; Tissue Doppler Ultrasound; Echocardiography; Ranolazine

Treatments: Drug: ranolazine

Study type: Interventional

Funder types: Other

Identifiers

NCT00574756

070480

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups

1

Other group

Description:

Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks

Treatment:

Drug: ranolazine

2

Other group

Description:

Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks

Treatment:

Drug: ranolazine