PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

Heart Failure With Preserved Ejection Fraction Clinical Trial

— PRIORITY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04745013
• Other study ID #: T004420N
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: November 2022
• Source: KU Leuven
• Contact: Véronique Cornelissen, PhD
• Phone: +32 16 3 29152
• Email: véronique.cornelissen[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: December 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Behavioral:
• PRIORITY
PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart
• Usual care
Only a written personalized exercise prescription will be provided.

Locations

Country	Name	City	State
Belgium	UZA	Antwerp
Belgium	Jessa Hospital Hasselt	Hasselt
Belgium	UHasselt	Hasselt

Sponsors (5)

Lead Sponsor	Collaborator
KU Leuven	Hasselt University, Universitaire Ziekenhuizen KU Leuven, University Ghent, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

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