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

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

PRIORITY

Usual care

About this trial

This is an interventional prevention trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men and women (HF stage A) aged 35-80 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

Sites / Locations

UZARecruiting
Jessa Hospital HasseltRecruiting
UHasseltRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRIORITY

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in cardiorespiratory fitness

Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion

Secondary Outcome Measures

Full Information

NCT ID

NCT04745013

First Posted

February 4, 2021

Last Updated

November 30, 2022

Sponsor

KU Leuven

Collaborators

Hasselt University, University Hospital, Antwerp, University Ghent, Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT04745013

Brief Title

PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Hasselt University, University Hospital, Antwerp, University Ghent, Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRIORITY

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PRIORITY

Intervention Description

PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart

Intervention Type

Behavioral

Intervention Name(s)

Usual care

Intervention Description

Only a written personalized exercise prescription will be provided.

Primary Outcome Measure Information:

Title

Changes in cardiorespiratory fitness

Description

Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion

Time Frame

1- and 2-year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Véronique Cornelissen, PhD

Phone

+32 16 3 29152

véronique.cornelissen@kuleuven.be

First Name & Middle Initial & Last Name or Official Title & Degree

Youri Bekhuis, MD

youri.bekhuis@uzleuven.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Véronique Cornelissen, PhD

Organizational Affiliation

KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZA

City

Antwerp

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emeline Vancraenenbroeck

Facility Name

Jessa Hospital Hasselt

City

Hasselt

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Youri Bekhuis, MD

Facility Name

UHasselt

City

Hasselt

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominique Hansen, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

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