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

October 17, 2018 updated by: Montreal Heart Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1N6
        • Centre for preventive medicine and physical activity of the Montreal Heart Institute (Centre ÉPIC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymphocyte GRK2 mRNA level
Time Frame: at baseline and following 12 weeks exercise training intervention
change in lymphocyte GRK2 mRNA levels
at baseline and following 12 weeks exercise training intervention

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting glucose
Time Frame: at baseline and following 12 weeks exercise training intervention
change in fasting glucose
at baseline and following 12 weeks exercise training intervention
serum lipids
Time Frame: at baseline and following 12 weeks exercise training intervention
change in serum lipids
at baseline and following 12 weeks exercise training intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Investigators

  • Principal Investigator: Anil Nigam, MD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

October 16, 2018

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1509

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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