Effects of Ranolazine and Exercise on Daily Physical Activity Trial (EREDA)

Duke University

Status and phase: Completed; Phase 4

Conditions: Chronic Stable Angina

Treatments: Drug: Placebo; Behavioral: Aerobic Exercise; Drug: Ranolazine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01948310

Pro00045794

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented CAD diagnosis
• Stable angina ≥ 3 months

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Ranolazine plus Exercise

Active Comparator group

Description:

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.

Treatment:

Drug: Ranolazine

Behavioral: Aerobic Exercise

Placebo plus Exercise

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Aerobic Exercise

Drug: Placebo