Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

Study Overview
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Brief Summary
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Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and additionally diastolic function (assessed echocardiographically). The investigators hypothesize that exercise training reverses HFpEF and that intensity of exercise training is more important than duration.

Official Title
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Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure- Clinical Study

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Behavioral: High Intensity Exercise
* Behavioral: Moderate Continuous Exercise
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary (structured exercise < 2x 30 min/wk) At least 40 years old Preserved systolic function LVEF > 50% Signs and symptoms of heart failure class NYHA II or III Diastolic dysfunction (E/é > 15 or E/é 8-15 and NT-proBNP > 220 pg/ml) Clinically stable for >= 6 weeks Optimal medical treatment for >= 6 weeks Written informed consent Exclusion Criteria: Non- HFpEF causes for HF symptoms (significant valvular or coronary disease, uncontrolled hypertension or arrhythmias, primary cardiomyopathies) Significant pulmonary disease (FEV1 < 50% predicted, COPD GOLD III-IV) Inability to exercise or conditions that may interfere with exercise intervention Myocardial infarction in the previous three months Signs of ischemia during exercise testing Comorbidity that may influence one- year prognosis Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Exercise<br>Patients perform interval- type endurance exercise at high intensity | Behavioral: High Intensity Exercise<br> <br> |
| Active Comparator: Moderate Continuous Exercise<br>Patients perform endurance exercise at moderate intensity | Behavioral: Moderate Continuous Exercise<br> <br> |
| Sham Comparator: Usual Care<br>Patients receive advice on being physically active as well as usual care | Behavioral: Usual Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak VO2 after three months | Change in Peak VO2 after three month intervention | Baseline and three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in E/e' (representing diastolic filling pressure) at baseline and three months | Change in E/e' (representing diastolic filling pressure) at baseline and three months | three months | 
| Change in E/e' at baseline and 12 months | Change in E/e' at baseline and 12 months | 12 months | 
| Change in Peak VO2 at baseline and 12 months | Change in Peak VO2 at baseline and 12 months | 12 months | 
| Change in NTproBNP at baseline and three months | Change in NTproBNP at baseline and three months | three months | 
| Change in NTproBNP at baseline and 12 months | Change in NTproBNP at baseline and 12 months | 12 months | 
| Change in health related quality of life at baseline and three months | Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and three months | three months | 
| Change in health related Quality of life at baseline and 12 months | Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and 12 months | 12 months | 
| Change in Left Atrial Volume Index (LAVI) at baseline and three months | Change in Left Atrial Volume Index (LAVI) at baseline and three months | three months | 
| Change in Left Atrial Volume Index (LAVI) at baseline and 12 months | Change in Left Atrial Volume Index (LAVI) at baseline and 12 months | 12 months | 
| Change in e' medial at baseline and three months | Change in e' medial at baseline and three months | three months | 
| Change in e' at baseline and 12 months | Change in e' at baseline and 12 months | 12 months | 
| Change in submaximal exercise capacity at baseline and three months | submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1) | three months | 
| Change in submaximal exercise capacity at baseline and 12 months | Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1) | 12 months | 
| Change in VE/VCO2 slope at baseline and three months | Change in VE/VCO2 slope at baseline and three months | three months | 
| Change in VE/VCO2 slope at baseline and 12 months | Change in VE/VCO2 slope at baseline and 12 months | 12 months | 
| Change in Flow Mediated Dilation (FMD) at baseline and three months | Change in Flow Mediated Dilation (FMD) at baseline and three months | three months | 
| Change in Flow Mediated Dilation (FMD) at baseline and 12 months | Change in Flow Mediated Dilation (FMD) at baseline and 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diastolic heart failure, Heart failure with preserved ejection fraction, exercise