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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01948310
First received: September 17, 2013
Last updated: June 29, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Chronic Stable Angina
Drug: Ranolazine
Behavioral: Aerobic Exercise
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ranolazine and Exercise on Daily Physical Activity Trial

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in peak oxygen consumption [ Time Frame: Week 1, Week 2 and Week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in treatment satisfaction as measured by the seattle angina questionnaire [ Time Frame: Week 1, Week 2 and Week 13 ] [ Designated as safety issue: No ]
  • Change in total daily energy expenditure [ Time Frame: Week 1, Week 2 and Week 13 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: December 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948310

Locations
United States, North Carolina
Duke Center for Living
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Gilead Sciences
Investigators
Principal Investigator: William E Kraus, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01948310     History of Changes
Other Study ID Numbers: Pro00045794 
Study First Received: September 17, 2013
Last Updated: June 29, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2016