Status:
UNKNOWN
PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Hasselt University
University Hospital, Antwerp
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
30-85 years
Phase:
NA
Brief Summary
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT04745013
Start Date
September 1 2021
End Date
December 1 2025
Last Update
December 2 2022
Active Locations (3)
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1
UZA
Antwerp, Belgium
2
Jessa Hospital Hasselt
Hasselt, Belgium
3
UHasselt
Hasselt, Belgium