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Ranolazine in Ischemic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01345188
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : September 6, 2018
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy Chest Pain Dyspnea Drug: Ranexa Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (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
Study Start Date : April 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Anginal Frequency [ Time Frame: 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.

  2. Quality of Life [ Time Frame: 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.


  3. Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345188


Locations
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United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Midwest Cardiovascular Research Foundation
Gilead Sciences
Investigators
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Principal Investigator: Nicolas W Shammas, MD Midwest Cardiovascular Research Foundation
More Information
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Responsible Party: Dr. Nicolas Shammas, Principal Investigator, MD, Midwest Cardiovascular Research Foundation
ClinicalTrials.gov Identifier: NCT01345188    
Other Study ID Numbers: IN-US-259-D032
First Posted: April 29, 2011    Key Record Dates
Results First Posted: September 6, 2018
Last Update Posted: March 4, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Dyspnea
Cardiomyopathies
Chest Pain
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Pain
Neurologic Manifestations
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action