Ranolazine in Ischemic Cardiomyopathy

This study has been completed.

Sponsor:

Collaborator:

Gilead Sciences

Information provided by (Responsible Party):

Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation

ClinicalTrials.gov Identifier:

NCT01345188

First received: April 28, 2011

Last updated: September 24, 2014

Last verified: September 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cardiomyopathy Chest Pain Dyspnea	Drug: Ranexa Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Cardiomyopathy Chest Pain

Drug Information available for: Ranolazine

U.S. FDA Resources

Further study details as provided by Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation:

Primary Outcome Measures:

Combined endpoint of improvement in chest pain symptoms with Ranexa assessed by Standardized Angina Questionnaire or dyspnea using the Rose Dyspnea Scale (RDS)Questionnaire [ Time Frame: 12 weeks ]


Enrollment:	28
Study Start Date:	April 2011
Study Completion Date:	April 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ranolazine 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug: Ranexa 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. Other Name: Ranolazine
Placebo Comparator: Placebo 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug: Placebo 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Anginal chest pain or dyspnea
Documentation of non treatable or optimally treated coronary artery disease
Ejection Fraction of less than or equal to 40%

Exclusion Criteria:

Less than 18 years of age
Pregnant or breast feeding
Patients with non ischemic cardiomyopathy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345188

Locations


United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803

Sponsors and Collaborators

Midwest Cardiovascular Research Foundation

Gilead Sciences

Investigators


Principal Investigator:	Nicolas W Shammas, MD	Midwest Cardiovascular Research Foundation

More Information


Responsible Party:	Dr. Nicolas Shammas, Principal Investigator, MD, Midwest Cardiovascular Research Foundation
ClinicalTrials.gov Identifier:	NCT01345188 History of Changes
Other Study ID Numbers:	IN-US-259-D032
Study First Received:	April 28, 2011
Last Updated:	September 24, 2014

Additional relevant MeSH terms:


Cardiomyopathies Dyspnea Chest Pain Heart Diseases Cardiovascular Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory	Signs and Symptoms Pain Neurologic Manifestations Nervous System Diseases Ranolazine Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 27, 2017

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