Myocardial InfarctionEXIT-VNCT02048696
Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction
A study testing Secondary prevention and cardiac rehabilitation clinic in people with Myocardial Infarction and Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Heart Failure, Coronary Artery Disease
- What is being tested?
- Secondary prevention and cardiac rehabilitation clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to 16 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for preventive medicine and physical activity of the Montreal Heart Institute (Centre ÉPIC)
Montreal, Quebec, H1T 1N6
About this study
Official title: 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.
Read the 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.
- Being tested
- Secondary prevention and cardiac rehabilitation clinic
- 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
- Medical subject headings
- Myocardial Infarction, Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary prevention and cardiac rehabilitation clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | 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. Receives: Other: Secondary prevention and cardiac rehabilitation clinic |
| control | No intervention | Individuals in this group are offered current ACC/AHA recommendations on physical activity in patients post-myocardial infarction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte GRK2 mRNA level
change in lymphocyte GRK2 mRNA levels
Measured: at baseline and following 12 weeks exercise training intervention
Secondary outcomes (9)
Left ventricular systolic function
change in left ventricular systolic function
Measured: at baseline and following 12 weeks exercise training intervention
Left ventricular dimensions
Change in left ventricular dimensions
Measured: at baseline and following 12 weeks exercise training intervention
Plasma epinephrine
change in plasma epinephrine
Measured: at baseline and following 12 weeks exercise training intervention
heart rate variability
change change in autonomic tone
Measured: at baseline and following 12 weeks exercise training intervention
exercise capacity (VO2max)
Change before and after exercise training
Measured: at baseline and following 12 weeks exercise training intervention
ambulatory blood pressure
Change in awake and 24h blood pressure
Measured: at baseline and following 12 weeks exercise training intervention
Plasma brain natriuretic peptide
change in plasma brain naturietic peptide
Measured: at baseline and following 12 weeks exercise training intervention
Maximal cardiac output and stroke volume using electrical bioimpedance
change in maximal cardiac output and stroke volume
Measured: at baseline and following 12 weeks exercise training intervention
lymphocyte GRK2 protein levels
change in lymphocyte GRK2 protein levels
Measured: at baseline and following 12 weeks exercise training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion1 Feb 2016
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anil Nigam, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048696
- Sponsor's protocol ID
- 13-1509
- Acronym
- EXIT-V
- Status last verified
- Oct 2018
- First submitted
- 22 Jan 2014
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gayda M, Trachsel LD, Besnier F, Boidin M, Lalonge J, Bherer L, Juneau M, Lepretre PM, Nigam A. Effects of different exercise training programs on post-exercise [Formula: see text]O2 recovery responses in patients with coronary heart disease. Eur J Appl Physiol. 2026 Jun;126(6):3393-3406. doi: 10.1007/s00421-026-06146-4. Epub 2026 Feb 25.
PubMed 41739167Trachsel 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.
PubMed 33096006Trachsel 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.
PubMed 31837947
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction: The EXercise Interval Training - V Study
- ClinicalTrials.gov ID
- NCT02048696
- Acronym / sponsor ID
- EXIT-V / 13-1509
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Secondary prevention and cardiac rehabilitation clinicSecondary 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. |
| control | No intervention | –Individuals in this group are offered current ACC/AHA recommendations on physical activity in patients post-myocardial infarction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary prevention and cardiac rehabilitation clinicSecondary 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 | Exercise training |
Primary outcome
Lymphocyte GRK2 mRNA level
Time frame: at baseline and following 12 weeks exercise training intervention
change in lymphocyte GRK2 mRNA levels
9 secondary outcomes
Left ventricular systolic function
Time frame: at baseline and following 12 weeks exercise training intervention
Left ventricular dimensions
Time frame: at baseline and following 12 weeks exercise training intervention
Plasma epinephrine
Time frame: at baseline and following 12 weeks exercise training intervention
heart rate variability
Time frame: at baseline and following 12 weeks exercise training intervention
exercise capacity (VO2max)
Time frame: at baseline and following 12 weeks exercise training intervention
ambulatory blood pressure
Time frame: at baseline and following 12 weeks exercise training intervention
Plasma brain natriuretic peptide
Time frame: 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
lymphocyte GRK2 protein levels
Time frame: at baseline and following 12 weeks exercise training intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Derived from this study: PubMed 41739167Gayda M, Trachsel LD, Besnier F, Boidin M, Lalonge J, Bherer L, Juneau M, Lepretre PM, Nigam A. Effects of different exercise training programs on post-exercise [Formula: see text]O2 recovery responses in patients with coronary heart disease. Eur J Appl Physiol. 2026 Jun;126(6):3393-3406. doi: 10.1007/s00421-026-06146-4. Epub 2026 Feb 25.
- Derived from this study: PubMed 33096006Trachsel 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.
- Derived from this study: PubMed 31837947Trachsel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Nigam, MD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondary prevention and cardiac rehabilitation clinic in people with Myocardial Infarction and Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte GRK2 mRNA level (time frame: at baseline and following 12 weeks exercise training intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048696, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.