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NCT00574756 Clinical Trial

Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Echocardiography Clinical Trial

Official title:
The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00574756
Other study ID # 070480
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2007
Est. completion date March 2010

Study information
Verified date July 2019
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 14
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• ranolazine
extended release 500 mg twice a day for two weeks

Locations
Country Name City State
United States UCSD Medical Center San Diego California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in E/Ea 2 weeks
Secondary changes in mitral inflow parameters (E, A, IVRT, DT) 2 weeks
Secondary Changes in tissue doppler parameters (Ea, Aa) 2 weeks
Secondary Changes in pulmonary venous inflow (S, D, a reversal) 2 weeks
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