PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart (PRIORITY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Behavioral: PRIORITY; Behavioral: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Véronique Cornelissen, PhD; Phone Number: +32 16 3 29152; Email: véronique.cornelissen@kuleuven.be
• Study Contact Backup: Name: Youri Bekhuis, MD; Email: youri.bekhuis@uzleuven.be

Study Locations

• Belgium
  • Antwerp, Belgium
    • Recruiting
    • UZA
    • Contact: Emeline Vancraenenbroeck
  • Hasselt, Belgium
    • Recruiting
    • Jessa Hospital Hasselt
    • Contact: Youri Bekhuis, MD
  • Hasselt, Belgium
    • Recruiting
    • UHasselt
    • Contact: Dominique Hansen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRIORITY; Patients randomized to the hybrid exercise intervention (PRIORITY) will receive a personalized exercise prescription generated by the EXPERT tool which will then be person-tailored by the physiotherapist during one-on-one physical activity consultation. Over a period of one year, patients will participate in 18 supervised center-based exercise sessions in adjunct to a remotely monitored and guided home-based exercise intervention.	Behavioral: PRIORITY; PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart
PLACEBO_COMPARATOR: Usual care; The usual care group will receive from the physiotherapist a personalized written exercise prescription that includes an individually tailored recommendation on frequency, intensity, type, time and volume of exercise. This exercise prescription will be generated by means of the EXPERT tool. No counselling or guidance on objective measures of physical activity by means of wearables or platform will be provided.	Behavioral: Usual care; Only a written personalized exercise prescription will be provided.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Hasselt University; University Hospital, Antwerp; University Ghent
• Investigators: Principal Investigator: Véronique Cornelissen, PhD, KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (ACTUAL): February 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: T004420N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No