Ranolazine in Ischemic Cardiomyopathy

Midwest Cardiovascular Research Foundation

Status and phase: Completed; Phase 4

Conditions: Cardiomyopathy; Dyspnea; Chest Pain

Treatments: Drug: Placebo; Drug: Ranexa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01345188

IN-US-259-D032

Details and patient eligibility

About

Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
2. Anginal chest pain or dyspnea
3. Documentation of non treatable or optimally treated coronary artery disease
4. Ejection Fraction of less than or equal to 40%

Exclusion criteria

1. Less than 18 years of age
2. Pregnant or breast feeding
3. Patients with non ischemic cardiomyopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

Ranolazine

Active Comparator group

Description:

1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Treatment:

Drug: Ranexa

Placebo

Placebo Comparator group

Description:

1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Treatment:

Drug: Placebo