Clinical trial NCT04745013: PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Hasselt University
name: University Hospital, Antwerp
name: University Ghent
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2021-02-09
Enrollment: 312
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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 criteria: 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

Primary outcomes:
measure: Changes in cardiorespiratory fitness
timeFrame: 1- and 2-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: UZA
city: Hasselt
country: Belgium
facility: Jessa Hospital Hasselt
city: Hasselt
country: Belgium
facility: UHasselt
Study officials:
affiliation: KU Leuven
name: Véronique Cornelissen, PhD
role: PRINCIPAL_INVESTIGATOR
References: