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

Primary Purpose

Myocardial Infarction, Heart Failure, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Secondary prevention and cardiac rehabilitation clinic
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Centre for preventive medicine and physical activity of the Montreal Heart Institute (Centre ÉPIC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training

control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Lymphocyte GRK2 mRNA level
change in lymphocyte GRK2 mRNA levels

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2014
Last Updated
October 17, 2018
Sponsor
Montreal Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02048696
Brief Title
Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction
Acronym
EXIT-V
Official Title
Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction: The EXercise Interval Training - V Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 1, 2016 (Actual)
Study Completion Date
October 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montreal Heart Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
Individuals in this group are offered current ACC/AHA recommendations on physical activity in patients post-myocardial infarction.
Intervention Type
Other
Intervention Name(s)
Secondary prevention and cardiac rehabilitation clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lymphocyte GRK2 mRNA level
Description
change in lymphocyte GRK2 mRNA levels
Time Frame
at baseline and following 12 weeks exercise training intervention
Secondary Outcome Measure Information:
Title
Left ventricular systolic function
Description
change in left ventricular systolic function
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
Left ventricular dimensions
Description
Change in left ventricular dimensions
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
Plasma epinephrine
Description
change in plasma epinephrine
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
heart rate variability
Description
change change in autonomic tone
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
exercise capacity (VO2max)
Description
Change before and after exercise training
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
ambulatory blood pressure
Description
Change in awake and 24h blood pressure
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
Plasma brain natriuretic peptide
Description
change in plasma brain naturietic peptide
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
Maximal cardiac output and stroke volume using electrical bioimpedance
Description
change in maximal cardiac output and stroke volume
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
lymphocyte GRK2 protein levels
Description
change in lymphocyte GRK2 protein levels
Time Frame
at baseline and following 12 weeks exercise training intervention
Other Pre-specified Outcome Measures:
Title
Fasting glucose
Description
change in fasting glucose
Time Frame
at baseline and following 12 weeks exercise training intervention
Title
serum lipids
Description
change in serum lipids
Time Frame
at baseline and following 12 weeks exercise training intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Nigam, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for preventive medicine and physical activity of the Montreal Heart Institute (Centre ÉPIC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1N6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33096006
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.
Results Reference
derived
PubMed Identifier
31837947
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.
Results Reference
derived

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Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction

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