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

Coronary Artery Disease Clinical Trial

— EXIT-V  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048696
• Other study ID #: 13-1509
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 16, 2018

Study information

• Verified date: October 2018
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 16, 2018
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre for preventive medicine and physical activity of the Montreal Heart Institute (Centre ÉPIC)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting glucose	change in fasting glucose	at baseline and following 12 weeks exercise training intervention
Other	serum lipids	change in serum lipids	at baseline and following 12 weeks exercise training intervention
Primary	Lymphocyte GRK2 mRNA level	change in lymphocyte GRK2 mRNA levels	at baseline and following 12 weeks exercise training intervention
Secondary	Left ventricular systolic function	change in left ventricular systolic function	at baseline and following 12 weeks exercise training intervention
Secondary	Left ventricular dimensions	Change in left ventricular dimensions	at baseline and following 12 weeks exercise training intervention
Secondary	Plasma epinephrine	change in plasma epinephrine	at baseline and following 12 weeks exercise training intervention
Secondary	heart rate variability	change change in autonomic tone	at baseline and following 12 weeks exercise training intervention
Secondary	exercise capacity (VO2max)	Change before and after exercise training	at baseline and following 12 weeks exercise training intervention
Secondary	ambulatory blood pressure	Change in awake and 24h blood pressure	at baseline and following 12 weeks exercise training intervention
Secondary	Plasma brain natriuretic peptide	change in plasma brain naturietic peptide	at baseline and following 12 weeks exercise training intervention
Secondary	Maximal cardiac output and stroke volume using electrical bioimpedance	change in maximal cardiac output and stroke volume	at baseline and following 12 weeks exercise training intervention
Secondary	lymphocyte GRK2 protein levels	change in lymphocyte GRK2 protein levels	at baseline and following 12 weeks exercise training intervention