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Ranolazine in Ischemic Cardiomyopathy

Primary Purpose

Cardiomyopathy, Chest Pain, Dyspnea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranexa
Placebo
Sponsored by
Midwest Cardiovascular Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Midwest Cardiovascular Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ranolazine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anginal Frequency
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
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)
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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2011
Last Updated
February 20, 2020
Sponsor
Midwest Cardiovascular Research Foundation
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01345188
Brief Title
Ranolazine in Ischemic Cardiomyopathy
Official Title
Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwest Cardiovascular Research Foundation
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Chest Pain, Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Ranexa
Other Intervention Name(s)
Ranolazine
Intervention Description
1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Primary Outcome Measure Information:
Title
Anginal Frequency
Description
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.
Time Frame
12 weeks
Title
Quality of Life
Description
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.
Time Frame
12 weeks
Title
Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas W Shammas, MD
Organizational Affiliation
Midwest Cardiovascular Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States

12. IPD Sharing Statement

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Ranolazine in Ischemic Cardiomyopathy

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