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Completed

NCT Number: NCT02048696

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Montreal, Quebec, H1T 1N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Secondary prevention and cardiac rehabilitation clinic

Other

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 outcomes

  1. Lymphocyte GRK2 mRNA level

    Time frame: at baseline and following 12 weeks exercise training intervention

    change in lymphocyte GRK2 mRNA levels

Secondary outcomes

  1. Left ventricular systolic function

    Time frame: at baseline and following 12 weeks exercise training intervention

    change in left ventricular systolic function

  2. Left ventricular dimensions

    Time frame: at baseline and following 12 weeks exercise training intervention

    Change in left ventricular dimensions

  3. Plasma epinephrine

    Time frame: at baseline and following 12 weeks exercise training intervention

    change in plasma epinephrine

  4. heart rate variability

    Time frame: at baseline and following 12 weeks exercise training intervention

    change change in autonomic tone

  5. exercise capacity (VO2max)

    Time frame: at baseline and following 12 weeks exercise training intervention

    Change before and after exercise training

  6. ambulatory blood pressure

    Time frame: at baseline and following 12 weeks exercise training intervention

    Change in awake and 24h blood pressure

  7. Plasma brain natriuretic peptide

    Time frame: at baseline and following 12 weeks exercise training intervention

    change in plasma brain naturietic peptide

  8. 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

  9. lymphocyte GRK2 protein levels

    Time frame: at baseline and following 12 weeks exercise training intervention

    change in lymphocyte GRK2 protein levels

Other outcomes

  1. Fasting glucose

    Time frame: at baseline and following 12 weeks exercise training intervention

    change in fasting glucose

  2. serum lipids

    Time frame: at baseline and following 12 weeks exercise training intervention

    change in serum lipids

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

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

Acronym: EXIT-V

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jan 29, 2014
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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