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

KU Leuven3 sites in 1 country312 target enrollmentSeptember 1, 2021

ConditionsHeart Failure With Preserved Ejection Fraction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure With Preserved Ejection Fraction
Sponsor: KU Leuven
Enrollment: 312
Locations: 3
Primary Endpoint: Changes in cardiorespiratory fitness
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2021

End Date

December 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

KU Leuven

Responsible Party

Principal Investigator

Véronique Cornelissen

Professor

KU Leuven

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