Effects of Ranolazine and Exercise on Daily Physical Activity Trial
- Conditions
- Chronic Stable Angina
- Interventions
- Registration Number
- NCT01948310
- Lead Sponsor
- Duke University
- Brief Summary
The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Documented CAD diagnosis
- Stable angina ≥ 3 months
- Class III or IV heart failure
- Myocardial Infarction or coronary revascularization procedure within 2 months
- QT interval > 500ms or prescribed medication known to prolong the QTc interval
- Contraindicated Medications
- Metformin dose > 1700mg/day
- Class Ia, Ic and III anti-arrhythmics
- CYP3A inhibitors
- Simvastatin >20mg/day
- Severe renal disease (< 30ml/min creatinine clearance)
- Currently on dialysis
- Lack of transportation to the exercise and testing facilities
- Implanted pacemaker that is not rate responsive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo plus Exercise Aerobic Exercise Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. Placebo plus Exercise Placebo Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. Ranolazine plus Exercise Aerobic Exercise Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. Ranolazine plus Exercise Ranolazine Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
- Primary Outcome Measures
Name Time Method Change in Peak Oxygen Consumption (VO2 Max) Baseline, Week 2 and Week 14 This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.
- Secondary Outcome Measures
Name Time Method Change in Total Daily Energy Expenditure Week 1, Week 4 and Week 14 Total daily physical activity is measured via Actigraph GT3X accelerometers. Accelerometers will be worn for 7 days pre-drug, post-drug/pre-exercise (week 4) and again in the final month of the exercise intervention (week 13)
Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire Baseline, Week 2 and Week 14 The Treatment Satisfaction scale is one of five scales of the Seattle Angina Questionnaire. The possible range of scores is 0 to 100, with higher scores indicating better quality of life.
Trial Locations
- Locations (1)
Duke Center for Living
🇺🇸Durham, North Carolina, United States