PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

Not Applicable

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT04745013
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Study Start: 2021-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-02
• Primary Completion: 2024-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (3)

UZA; 🇧🇪 Antwerp, Belgium

Jessa Hospital Hasselt; 🇧🇪 Hasselt, Belgium

UHasselt; 🇧🇪 Hasselt, Belgium