Effects of Ranolazine and Exercise on Daily Physical Activity Trial

Chronic Stable Angina Clinical Trial

— EREDA  

Official title:

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948310
• Other study ID #: Pro00045794
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2013
• Last updated: November 13, 2017
• Start date: December 2013
• Est. completion date: October 10, 2016

Study information

• Verified date: November 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 10, 2016
• Est. primary completion date: October 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Stable Angina

Intervention

Drug:
• Ranolazine
Comparison of Ranolazine 1000mg twice per day versus placebo twice per day

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

Locations

Country	Name	City	State
United States	Duke Center for Living	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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