Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
Information source: Midwest Cardiovascular Research Foundation
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiomyopathy; Chest Pain; Dyspnea
Intervention: Ranexa (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Midwest Cardiovascular Research Foundation Official(s) and/or principal investigator(s):
Nicolas W Shammas, MD, Principal Investigator, Affiliation: Midwest Cardiovascular Research Foundation
Overall contact:
Nicolas W Shammas, MD, Phone: (563) 320-0263, Email: shammas@mchsi.com
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.
Clinical Details
Official title: Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Combined endpoint of improvement in chest pain symptoms with Ranexa assessed by Standardized Angina Questionnaire or dyspnea using the Rose Dyspnea Scale (RDS)Questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Nicolas W Shammas, MD, Phone: (563) 320-0263, Email: shammas@mchsi.com
Midwest Cardiovascular Research Foundation, Davenport, Iowa 52803, United States; Recruiting
Nicolas W Shammas, MD, Phone: 563-320-0263, Email: shammas@mchsi.com
Nicolas W Shammas, MD, Principal Investigator
Additional Information
Starting date: April 2011
Last updated: November 5, 2012
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