EXIT-V: Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction

Sponsor

Montreal Heart Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02048696

Collaborator

(none)

Enrollment

Location

Arms

56.4

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients who have suffered a heart attack are at risk of developing worsening heart function and heart failure. Exercise training has a beneficial effect on heart function and prevents heart failure. The aim of the current study is to investigate the effect of exercise training on heart function in patients who have suffered a heart attack.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Heart Failure Coronary Artery Disease	Other: Secondary prevention and cardiac rehabilitation clinic	N/A

Detailed Description

Patients who have suffered a myocardial infarction are at significant risk for developing heart failure and progressive left ventricular dysfunction One of the proposed mechanisms responsible for this observation is reduction in myocardial beta-adrenergic receptor density due to elevated cell membrane protein G - protein coupled receptor kinase -2 (GRK2).

It is known that exercise training preserves heart function in patients who have suffered a myocardial infarction. The mechanism for this is not clear.

The purpose of this study is to examine the effect of exercise training on myocardial function and GRK2 levels in patients who have suffered a myocardial infarction, with the hypothesis that exercise training in this population reduces GRK2 levels and preserves or improves myocardial function.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction: The EXercise Interval Training - V Study

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Oct 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise training Secondary prevention and cardiac rehabilitation clinic of the Montreal Heart Institute. Subjects will undergo twice weekly exercise training with high intensity interval training for a period of 12 weeks.	Other: Secondary prevention and cardiac rehabilitation clinic Secondary prevention and cardiac rehabilitation clinic of the Montreal Heart Institute. Subjects will undergo twice weekly exercise training with high intensity interval training for a period of 12 weeks.
No Intervention: control Individuals in this group are offered current ACC/AHA recommendations on physical activity in patients post-myocardial infarction.

Arm

Intervention/Treatment

Experimental: Exercise training

Secondary prevention and cardiac rehabilitation clinic of the Montreal Heart Institute. Subjects will undergo twice weekly exercise training with high intensity interval training for a period of 12 weeks.

Other: Secondary prevention and cardiac rehabilitation clinic

No Intervention: control

Individuals in this group are offered current ACC/AHA recommendations on physical activity in patients post-myocardial infarction.

Outcome Measures

Primary Outcome Measures

Lymphocyte GRK2 mRNA level [at baseline and following 12 weeks exercise training intervention]
change in lymphocyte GRK2 mRNA levels

Secondary Outcome Measures

Left ventricular systolic function [at baseline and following 12 weeks exercise training intervention]
change in left ventricular systolic function
Left ventricular dimensions [at baseline and following 12 weeks exercise training intervention]
Change in left ventricular dimensions
Plasma epinephrine [at baseline and following 12 weeks exercise training intervention]
change in plasma epinephrine
heart rate variability [at baseline and following 12 weeks exercise training intervention]
change change in autonomic tone
exercise capacity (VO2max) [at baseline and following 12 weeks exercise training intervention]
Change before and after exercise training
ambulatory blood pressure [at baseline and following 12 weeks exercise training intervention]
Change in awake and 24h blood pressure
Plasma brain natriuretic peptide [at baseline and following 12 weeks exercise training intervention]
change in plasma brain naturietic peptide
Maximal cardiac output and stroke volume using electrical bioimpedance [at baseline and following 12 weeks exercise training intervention]
change in maximal cardiac output and stroke volume
lymphocyte GRK2 protein levels [at baseline and following 12 weeks exercise training intervention]
change in lymphocyte GRK2 protein levels

Other Outcome Measures

Fasting glucose [at baseline and following 12 weeks exercise training intervention]
change in fasting glucose
serum lipids [at baseline and following 12 weeks exercise training intervention]
change in serum lipids

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute myocardial infarction
Complete revascularization: no residual major epicardial coronary artery coronary stenosis ≥ 70%; no residual left main coronary stenosis ≥ 40%.
Stage A-C heart failure, New York Heart Association class I-III.
Stable dose of medications during the 4 weeks prior to enrolment.
Able to perform a maximal cardiopulmonary stress test.
Capacity and willingness to provide sign informed consent.

Exclusion Criteria:

Pregnant
Coronary artery bypass surgery: patients post coronary artery bypass graft exhibit wall motion abnormalities that may interfere with speckle tracking analysis.
Incomplete revascularization with major epicardial coronary artery (left anterior descending, circumflex, or right coronary) stenosis ≥ 70%.
Myocardial necrosis in the absence of significant flow limiting coronary artery stenosis or thrombosis, with the exception of documented STEMI and successful thrombolytic therapy resulting on no significant residual epicardial coronary artery stenosis.
Significant valvular disease that is greater than moderate in severity
History of non-ischemic cardiomyopathy (dilated, restrictive, infiltrative cardiomyopathy, hypertrophic, LV non compaction, or Takotsubo cardiomyopathy)
Significant resting ECG abnormalities that preclude accurate speckle tracking.
Paced rhythm.
left bundle branch block
Atrial arrhythmias (ex. persistent/permanent atrial fibrillation, atrial flutter).
Frequent ventricular ectopics
Significant ventricular arrhythmias (non-sustained ventricular tachycardia or syncope).
New York Heart Association class IIIb - IV symptoms.
Severe LV systolic dysfunction (Ejection fraction ≤ 30%)
Active decompensated heart failure with orthopnea or paroxysmal nocturnal dyspnea.
Uncontrolled resting arterial hypertension > 180/110 mmHg.
More than moderate systemic disease
Chronic inflammation or infection.
Any contraindication to exercise training or any condition limiting ability to partake in adequate exercise stress testing or training (peripheral artery disease, articular, neurologic, or psychiatric pathology)