PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04745013

Acronym

PRIORITY

Enrollment

312

Registered

2021-02-09

Start date

2021-09-01

Completion date

2025-12-31

Last updated

2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

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.

Interventions

BEHAVIORALPRIORITY

PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart

BEHAVIORALUsual care

Only a written personalized exercise prescription will be provided.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Belgium

Contacts

Primary ContactVéronique Cornelissen, PhD

véronique.cornelissen@kuleuven.be+32 16 3 29152

Backup ContactYouri Bekhuis, MD

youri.bekhuis@uzleuven.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026