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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stable Angina
• Intervention / Treatment: Drug: Ranolazine; Behavioral: Aerobic Exercise; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Center for Living

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ranolazine plus 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.	Drug: Ranolazine; Comparison of Ranolazine 1000mg twice per day versus placebo twice per day; Other Names: Renexa; Behavioral: Aerobic Exercise; 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 Comparator: Placebo plus 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.	Behavioral: Aerobic Exercise; 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); Drug: Placebo; Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peak Oxygen Consumption (VO2 Max)	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.	Baseline, Week 2 and Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire	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.	Baseline, Week 2 and Week 14
Change in Total Daily Energy Expenditure	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)	Week 1, Week 4 and Week 14

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: William E Kraus, MD, Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): October 10, 2016
• Study Completion (Actual): October 10, 2016

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Sodium Channel Blockers; Ranolazine
• Other Study ID Numbers: Pro00045794