Heart Failure With Preserved Ejection FractionPRIORITYNCT04745013
PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart
A study testing PRIORITY in people with Heart Failure With Preserved Ejection Fraction, run by KU Leuven at 3 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- PRIORITY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Sep 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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%)
Show all 9Show fewer
- NYHA class IV
- participation in another clinical interventional trial
- cognitive limitation
Trial locations and contacts
3 sites in 1 country.
Youri Bekhuis, MD contact
Belgium3 sites, 3 recruiting
- Recruiting
UZA
Antwerp
Emeline Vancraenenbroeck
- Recruiting
Jessa Hospital Hasselt
Hasselt
Youri Bekhuis, MD
- Recruiting
UHasselt
Hasselt
Dominique Hansen, PhD
About this study
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
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.
- Being tested
- PRIORITY, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIORITYBehavioural
PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart
Usual careBehavioural
Only a written personalized exercise prescription will be provided.
| Study group | Role | What they receive |
|---|---|---|
| PRIORITY | Experimental | 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. Receives: Behavioral: PRIORITY |
| Usual care | Placebo comparator | 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiorespiratory fitness
Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion
Measured: 1- and 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Sep 2021
- Primary completionJun 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University, University Hospital, Antwerp, University Ghent, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Véronique Cornelissen, KU Leuven
- Investigators
- Véronique Cornelissen, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745013
- Sponsor's protocol ID
- T004420N
- Acronym
- PRIORITY
- Status last verified
- Nov 2022
- First submitted
- 4 Feb 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Wilde C, Bekhuis Y, Kuznetsova T, Claes J, Claessen G, Coninx K, Decorte E, De Smedt D, Hansen D, Lannoo M, Van Craenenbroeck EM, Verhaeghe N, Cornelissen VA. Personalized remotely guided preventive exercise therapy for a healthy heart (PRIORITY): protocol for an assessor-blinded, multicenter randomized controlled trial. Front Cardiovasc Med. 2023 Jun 29;10:1194693. doi: 10.3389/fcvm.2023.1194693. eCollection 2023.
PubMed 37456813
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04745013
- Acronym / sponsor ID
- PRIORITY / T004420N
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Hasselt University, University Hospital, Antwerp, University Ghent, Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRIORITY | Experimental | Behavioral: PRIORITYPatients 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. |
| Usual care | Placebo comparator | Behavioral: Usual careThe 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIORITYPeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart | Behavioural | PRIORITY |
| Usual careOnly a written personalized exercise prescription will be provided. | Behavioural | Usual care |
Primary outcome
Changes in cardiorespiratory fitness
Time frame: 1- and 2-year follow-up
Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 37456813De Wilde C, Bekhuis Y, Kuznetsova T, Claes J, Claessen G, Coninx K, Decorte E, De Smedt D, Hansen D, Lannoo M, Van Craenenbroeck EM, Verhaeghe N, Cornelissen VA. Personalized remotely guided preventive exercise therapy for a healthy heart (PRIORITY): protocol for an assessor-blinded, multicenter randomized controlled trial. Front Cardiovasc Med. 2023 Jun 29;10:1194693. doi: 10.3389/fcvm.2023.1194693. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youri Bekhuis, MD contact
Véronique Cornelissen, PhD principal investigator
KU Leuven
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIORITY in people with Heart Failure With Preserved Ejection Fraction, run by KU Leuven at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Véronique Cornelissen, PhD (+32 16 3 29152, véronique.cornelissen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiorespiratory fitness (time frame: 1- and 2-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.