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PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

Recruiting
30-85 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Heart Failure With Preserved Ejection Fraction

NCT04745013

KU Leuven

27 January 2024

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