Effects of Ranolazine and Exercise on Daily Physical Activity Trial

• Status: Completed
• Trial end date: 2016-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

Criteria

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