Clinical trial NCT02048696: Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction
Official title: Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction: The EXercise Interval Training - V Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Heart Failure
Coronary Artery Disease
Keywords: Exercise training
High intensity interval training
left ventricular systolic function
G-protein related kinase 2
heart failure
myocardial infarction
coronary artery disease
beta adrenergic receptor
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Lymphocyte GRK2 mRNA level
timeFrame: at baseline and following 12 weeks exercise training intervention
Secondary outcomes:
measure: Left ventricular systolic function
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: Left ventricular dimensions
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: Plasma epinephrine
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: heart rate variability
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: exercise capacity (VO2max)
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: ambulatory blood pressure
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: Plasma brain natriuretic peptide
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: Maximal cardiac output and stroke volume using electrical bioimpedance
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: lymphocyte GRK2 protein levels
timeFrame: at baseline and following 12 weeks exercise training intervention
Other outcomes:
measure: Fasting glucose
timeFrame: at baseline and following 12 weeks exercise training intervention
measure: serum lipids
timeFrame: at baseline and following 12 weeks exercise training intervention
Locations:
city: Montreal
country: Canada
facility: Centre for preventive medicine and physical activity of the Montreal Heart Institute (Centre ÉPIC)
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Anil Nigam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trachsel LD, Boidin M, Henri C, Fortier A, Lalonge J, Juneau M, Nigam A, Gayda M. Women and men with coronary heart disease respond similarly to different aerobic exercise training modalities: a pooled analysis of prospective randomized trials. Appl Physiol Nutr Metab. 2021 May;46(5):417-425. doi: 10.1139/apnm-2020-0650. Epub 2020 Oct 23.
citation: Trachsel LD, Nigam A, Fortier A, Lalonge J, Juneau M, Gayda M. Moderate-intensity continuous exercise is superior to high-intensity interval training in the proportion of VO2peak responders after ACS. Rev Esp Cardiol (Engl Ed). 2020 Sep;73(9):725-733. doi: 10.1016/j.rec.2019.09.013. Epub 2019 Dec 16. English, Spanish.