Cardiomyopathy, Chest Pain, Dyspnea
Conditions
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.
Interventions
DRUGRanexa
1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
DRUGPlacebo
1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Sponsors
Gilead Sciences
Midwest Cardiovascular Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anginal Frequency | 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 Questionnaire | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants recruited from a cardiovascular clinic in Davenport, Iowa between 5/21/2012 and 11/22/2013
Pre-assignment details
A total of 36 patients assessed for eligibility. Excluded were 8 patients (did not meet inclusion criteria=4; declined to participate=3;other=1). 28 patients were included in this randomized cross-over study.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes both groups randomized to placebo and ranolazine | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Crossover Ranolazine/Placebo 6 Weeks | Lost to Follow-up | 1 |
| Randomization Ranolazine/Placebo 6 Weeks | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 8.4 |
| Diabetes Mellitus | 19 participants |
| Ejection Fraction | 33.1 Percentage STANDARD_DEVIATION 7.6 |
| Prior myocardial infarction | 23 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 6 / 24 | 2 / 24 |
| serious Total, serious adverse events | 2 / 24 | 0 / 24 |
Outcome results
Primary
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.
Time frame: 12 weeks
Population: Patients receiving ranolazine for 6 weeks and crossed over to placebo or vice versa. Higher number on the angina scale indicates less angina
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ranolazine | Anginal Frequency | 86.67 units on a scale |
| Placebo | Anginal Frequency | 74.44 units on a scale |
p-value: 0.058Paired t test
Primary
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.
Time frame: 12 weeks
Population: Patients with dsypnea. The score reflects difference between baseline and following treatment with ranolazine or placebo
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ranolazine | Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) | -0.45 units on a scale |
| Placebo | Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) | -0.34 units on a scale |
p-value: >0.05Wilcoxon Signed rank
Primary
Quality of Life Questionnaire
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ranolazine | Quality of Life Questionnaire | 72.22 units on a scale |
| Placebo | Quality of Life Questionnaire | 66.67 units on a scale |
p-value: 0.048Paired t test