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Completed

NCT Number: NCT01948310

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

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.

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Key information

Conditions

Chronic Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke Center for Living

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranolazine

Drug

Comparison of Ranolazine 1000mg twice per day versus placebo twice per day

Other names: Renexa

Aerobic Exercise

Behavioral

Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)

Placebo

Drug

Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day

Primary outcomes

  1. Change in Peak Oxygen Consumption (VO2 Max)

    Time frame: 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 outcomes

  1. Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire

    Time frame: 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.

  2. Change in Total Daily Energy Expenditure

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Gilead Sciences

Registry information

Acronym: EREDA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2013
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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