Ranolazine in Ischemic Cardiomyopathy
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ClinicalTrials.gov Identifier: NCT01345188 |
Recruitment Status :
Completed
First Posted : April 29, 2011
Results First Posted : September 6, 2018
Last Update Posted : March 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cardiomyopathy Chest Pain Dyspnea | Drug: Ranexa Drug: Placebo | Phase 4 |
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 |

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.
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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. |
- 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.
- 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.
- 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.

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

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
United States, Iowa | |
Midwest Cardiovascular Research Foundation | |
Davenport, Iowa, United States, 52803 |
Principal Investigator: | Nicolas W Shammas, MD | Midwest Cardiovascular Research Foundation |
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 |
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 |