PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

Study Overview
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Brief Summary
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In the PRIORITY study, we aim to provide the clinical evidence base for the use of a new hybrid exercise intervention, which includes remotely guided home-based exercise, as an accessible, clinical and cost-effective treatment to prevent the deleterious effects of sedentary aging on the heart and forestall the development and progression towards overt HFpEF.

Official Title
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A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Study to Compare the Clinical and Cost Efficacy of a New Hybrid Exercise Intervention PRIORITY Versus Usual Care

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Behavioral: PRIORITY
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women (HF stage A) aged > 30 yrs: treated or untreated patients with hypertension (blood pressure 130/80 - 159/99 mmHg) AND/OR Patients with prediabetes (impaired fasting glucose and/or insulin resistance) with either: Fasting plasma glucose: 100 to 125 mg/dL (5.6-6.9 mmol/L) Hemoglobine A1c: 5.7% to 6.4% Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index above 75% of population distribution (>2.0) AND/OR Patients with obesity with 30 kg/m² ≥ body mass index ≤ 42 kg/m² Patients with subclinical signs of diastolic dysfunction without symptoms (HF Stage B disease) Men and women with diagnosis of HF stage C: i.e. patients who have a total score ≥ 5 points according to the recent recommendation paper on how to diagnose heart failure with preserved ejection fraction from the Heart failure Association of ESC. All participants should be on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks before enrollment in the study. All participants should have internet access at home. Exclusion Criteria: significant illness during the last 6 weeks known severe ventricular arrhythmia with functional or prognostic significance significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing co-morbidity that may significantly negatively influence one-year prognosis functional or mental disability that may limit execution of prescribed exercise severe chronic obstructive pulmonary disease (FEV1 < 50%) NYHA class IV participation in another clinical interventional trial cognitive limitation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRIORITY<br>Patients randomized to the hybrid exercise intervention (PRIORITY) will receive a personalized exercise prescription generated by the EXPERT tool which will then be person-tailored by the physiotherapist during one-on-one physical activity consultation. Over a period of one year, patients will participate in 18 supervised center-based exercise sessions in adjunct to a remotely monitored and guided home-based exercise intervention. | Behavioral: PRIORITY<br>* PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart<br>|
| Placebo Comparator: Usual care<br>The usual care group will receive from the physiotherapist a personalized written exercise prescription that includes an individually tailored recommendation on frequency, intensity, type, time and volume of exercise. This exercise prescription will be generated by means of the EXPERT tool. No counselling or guidance on objective measures of physical activity by means of wearables or platform will be provided. | Behavioral: Usual care<br>* Only a written personalized exercise prescription will be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiorespiratory fitness | Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion | 1- and 2-year follow-up |