HFpEF - Heart Failure With Preserved Ejection FractionEXPOSURENCT06514820
Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure
An observational study of HFpEF - Heart Failure With Preserved Ejection Fraction, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jan 2024to 31 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of 50 patients with HFpEF, in which the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation will be tested using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing.
Who may be able to join
- Signs and symptoms of HF according to the Europeans Society of Cardiology guideline.
- LV ejection fraction ≥40%.
- HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test (Figure 1).
- >18 years of age
- In sinus rhythm
- Able to perform a bicycle exercise test
- Willing to sign informed consent
Who cannot join
- Body weight >140 kg
- Atrial fibrillation or other significant arrhythmia during the assessment
- Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)
- Myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft <3 months or untreated severe obstructive coronary artery stenosis
- More than moderate left-sided valve disease.
- Complex congenital heart disease.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Thomas M Gorter, MD, PhD
About this study
Official title: EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study
To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF.
Read the detailed description
The EXPOSURE study investigates the effects of epicardial fat on ventricular interdependence at peak exercise. Epicardial fat, the visceral fat situated directly adjacent to the heart, seems involved in the pathophysiology of heart failure with preserved ejection fraction (HFpEF). It has been suggested that an abundance of epicardial fat surrounding the heart within a closed pericardial sac may constrain the heart leading to ventricular interdependence. The study is an investigator initiatied, cross-sectional, observational study, including 50 patients with HFpEF. Patients will be stratified according to high and low epicardial fat volume measured with CMR. The primary outcome parameter is the difference in LV eccentricity index at peak exercise between the two groups. Pre-specified secondary outcome parameters between the subgroups are: 1) VO2-max, 2) LV and right ventricular (RV) diastolic strain rate, 3) slope of early LV/RV filling, 3) left and right atrial reservoir strain and emptying fraction, 4) pulmonary artery distensibility and pulsatility and 5) cardiac output, all at peak exercise. The amount of epicardial fat will be correlated with change in LV eccentricity index from rest to peak exercise, change in LV/RV diastolic strain rate, change in slope of LV/RV filling, change in atrial reservoir strain and emptying fraction, change in pulmonary artery distensibility and pulsatility, and change in cardiac output. All results will be also compared between men and women.
- Keywords
- Epicardial fat, HFpEF, Exercise MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular interdependence
the effect of epicardial fat on ventricular interdependence at peak exercise
Measured: Baseline
Secondary outcomes (8)
VO2-max
the effect of epicardial fat on VO2-max at peak exercise
Measured: Baseline
LV/RV diastolic strain rate
the effect of epicardial fat on ventricular diastolic strain rate measured on echocardiography at peak exercise
Measured: Baseline
slope of early LV/RV filling
the effect of epicardial fat on slope of early ventricular filling measured on echocardiography at peak exercise
Measured: Baseline
left and right atrial reservoir strain
the effect of epicardial fat on atrial emptying fraction measured on echocardiography at peak exercise
Measured: Baseline
left and right atrial emptying fraction
the effect of epicardial fat on atrial reservoir strain measured on echocardiography at peak exercise
Measured: Baseline
pulmonary artery distensibility
the effect of epicardial fat on pulmonary artery distensibility measured on echocardiography at peak exercise
Measured: Baseline
pulmonary artery pulsatility
the effect of epicardial fat on pulmonary artery pulsatility measured on echocardiography at peak exercise
Measured: Baseline
cardiac output
the effect of epicardial fat on cardiac output at peak exercise
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start16 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas M Gorter, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514820
- Sponsor's protocol ID
- EXPOSURE study
- Acronym
- EXPOSURE
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study
- ClinicalTrials.gov ID
- NCT06514820
- Acronym / sponsor ID
- EXPOSURE / EXPOSURE study
- Keywords
- Epicardial fat, HFpEF, Exercise MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF.
Detailed description
The EXPOSURE study investigates the effects of epicardial fat on ventricular interdependence at peak exercise. Epicardial fat, the visceral fat situated directly adjacent to the heart, seems involved in the pathophysiology of heart failure with preserved ejection fraction (HFpEF). It has been suggested that an abundance of epicardial fat surrounding the heart within a closed pericardial sac may constrain the heart leading to ventricular interdependence. The study is an investigator initiatied, cross-sectional, observational study, including 50 patients with HFpEF. Patients will be stratified according to high and low epicardial fat volume measured with CMR. The primary outcome parameter is the difference in LV eccentricity index at peak exercise between the two groups. Pre-specified secondary outcome parameters between the subgroups are: 1) VO2-max, 2) LV and right ventricular (RV) diastolic strain rate, 3) slope of early LV/RV filling, 3) left and right atrial reservoir strain and emptying fraction, 4) pulmonary artery distensibility and pulsatility and 5) cardiac output, all at peak exercise. The amount of epicardial fat will be correlated with change in LV eccentricity index from rest to peak exercise, change in LV/RV diastolic strain rate, change in slope of LV/RV filling, change in atrial reservoir strain and emptying fraction, change in pulmonary artery distensibility and pulsatility, and change in cardiac output. All results will be also compared between men and women.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 50 patients with HFpEF, in which the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation will be tested using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing.
Key inclusion criteria (7 listed)
- Signs and symptoms of HF according to the Europeans Society of Cardiology guideline.
- LV ejection fraction ≥40%.
- HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test (Figure 1).
- >18 years of age
- In sinus rhythm
Key exclusion criteria (6 listed)
- Body weight >140 kg
- Atrial fibrillation or other significant arrhythmia during the assessment
- Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)
- Myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft <3 months or untreated severe obstructive coronary artery stenosis
- More than moderate left-sided valve disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventricular interdependence
Time frame: Baseline
the effect of epicardial fat on ventricular interdependence at peak exercise
8 secondary outcomes
VO2-max
Time frame: Baseline
LV/RV diastolic strain rate
Time frame: Baseline
slope of early LV/RV filling
Time frame: Baseline
left and right atrial reservoir strain
Time frame: Baseline
left and right atrial emptying fraction
Time frame: Baseline
pulmonary artery distensibility
Time frame: Baseline
pulmonary artery pulsatility
Time frame: Baseline
cardiac output
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Thomas M Gorter, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HFpEF - Heart Failure With Preserved Ejection Fraction, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 6 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. 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 Thomas M Gorter, MD, PhD (+3150 361 6161, tm.gorter@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular interdependence (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.