Ranolazine in Ischemic Cardiomyopathy

Phase 4

Completed

• Conditions: Cardiomyopathy; Dyspnea; Chest Pain
• Interventions: Drug: Placebo; Drug: Ranexa

• Registration Number: NCT01345188
• Lead Sponsor: Midwest Cardiovascular Research Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2016-01-03
• Results First Submitted QC: 2018-08-05
• Results First Posted: 2018-09-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Ranolazine	Ranexa	1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Primary Outcome Measures

Name	Time	Method
Anginal Frequency	12 weeks	Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.
Quality of Life Questionnaire	12 weeks	Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life.; These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety.
Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)	12 weeks	RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.

Trial Locations

Locations (1)

Midwest Cardiovascular Research Foundation; 🇺🇸 Davenport, Iowa, United States