The SMARTEX Heart Failure Study

Study Overview
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Brief Summary
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This protocol describes a randomized multicenter clinical trial designed to test the hypothesis that a 12-week program of high-intensity interval training (HIIT) yields larger beneficial effects in stable heart failure patients than current practice, defined as either a similar training program with the same volume of moderate continuous training (MCT) or a recommendation of regular exercise at moderate intensity at individual choice (RRE).

Detailed Description
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Evaluation criteria are left ventricular dimensions and function measured by echocardiography, aerobic capacity measured as peak oxygen uptake, quality of life, and the level of physical activity by questionnaires. Assessments will be made before and after the training program and at one year follow-up. Safety of HIIT will be assessed as incidence of adverse effects during the training program. Clinical events will be recorded as worsening of heart failure requiring intensified drug therapy (diuretics), ventricular arrhythmia, hospitalization due to cardiovascular disease, and all-cause mortality at one year follow-up. The core study has been initiated and endorsed by the European Association for Cardiovascular Prevention and Rehabilitation, Section for Basic and Translational Research, under the European Society of Cardiology, and allows for sub-studies involving one or more of the participating centers. Preliminary calculations suggest that a total number of 200 patients randomized 1:1:1 to the three intervention groups is needed to detect larger beneficial effects with HIIT with a p-value of 0.05 and statistical power of 0.90 (primary endpoint is reverse remodeling, assessed by comparison between groups of change in left ventricular end-diastolic dimension from baseline to 12 weeks).

Official Title
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Study of Myocardial Recovery After Exercise Training in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: high-intensity interval training
* Behavioral: Moderate continuous training
* Behavioral: Recommendation of regular moderate exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congestive heart failure after myocardial infarction or dilated cardiomyopathy with: LVEF < 0.35, NYHA class II - III, Stable without any signs of worsening for at least 6 weeks, Minimum 3 months of optimal medical treatment, Previous revascularisation or CRT should be more than 6 months before inclusion. Exclusion Criteria: Significant intercurrent illness last 6 weeks, Known severe ventricular arrhythmia with functional or prognostic significance unless protected with ICD, Significant ischemia, Hemodynamic deterioration or exercise-induced arrhythmia at baseline testing, Other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc., Co-morbidity that may significantly influence one-year prognosis, Functional or mental disability that may limit exercise, Patients scheduled for heart transplant at time of inclusion, A habit of regular vigorous exercise or participation in a program of exercise training less than 6 months before inclusion, or participation in another clinical trial, Patients with COPD with FEV1 below 50% of expected values are excluded, Patients taking oral corticosteroids are excluded in all cases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Interval training<br>high-intensity Interval Training | Behavioral: high-intensity interval training<br>* 3 weekly sessions of high-intensity interval training in 12 weeks<br>|
| Experimental: 2 Moderate Training<br>Moderate continuous training | Behavioral: Moderate continuous training<br>* 3 weekly sessions of moderate continuous training for 12 weeks<br>|
| Active Comparator: 3 Recommendation of exercise<br>Recommendation of regular exercise at moderate intensity at individual choice | Behavioral: Recommendation of regular moderate exercise<br>* Recommendation of regular exercise at moderate intensity at individual choice. In addition patients will meet for treadmill walking in order to motivate for post intervention testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks |  | Baseline-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity |  | baseline-12 weeks- 1year | 
| quality of life |  | baseline - 12 weeks - 1 year | 
| level of physical activity |  | baseline-12 weeks- 1 year | 
| safety and adverse events |  | baseline-12 weeks - 1 year | 
| Change in Ejection fraction |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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All-cause heart failure patients, coronary artery disease etiology, dilated cardiomyopathy etiology