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

Primary Purpose

Chronic Stable Angina

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Aerobic Exercise
Placebo
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke Center for Living

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ranolazine plus Exercise

Placebo plus Exercise

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)

Full Information

First Posted
September 17, 2013
Last Updated
November 13, 2017
Sponsor
Duke University
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01948310
Brief Title
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Acronym
EREDA
Official Title
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 10, 2016 (Actual)
Study Completion Date
October 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine plus Exercise
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo plus Exercise
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Renexa
Intervention Description
Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
Primary Outcome Measure Information:
Title
Change in Peak Oxygen Consumption (VO2 Max)
Description
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.
Time Frame
Baseline, Week 2 and Week 14
Secondary Outcome Measure Information:
Title
Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire
Description
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.
Time Frame
Baseline, Week 2 and Week 14
Title
Change in Total Daily Energy Expenditure
Description
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)
Time Frame
Week 1, Week 4 and Week 14

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Kraus, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Center for Living
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

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