To investigate the negative effects of epicardial fat on cardiac function, morphology and pericardial restrain during exercise.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will be stratified according to high (>=100 ml/m2) and low (<100 ml/m2)
epicardial fat volume measured with CMR. The primary outcome parameter is the
difference in LV eccentricity index at peak exercise between the two groups.
Secondary outcome
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.
Background summary
Obesity is prevalent, also in The Netherlands, and has become one of the most
important risk factors for heart failure (HF), especially HF with preserved
ejection fraction (HFpEF). Obesity is defined as BMI >30 kg/m2, but this
general measurement provides limited information on the amount of adipose
tissue. Especially visceral adiposity imposes a huge risk for the development
of HFpEF. In particular epicardial fat, the visceral fat situated directly
adjacent to the heart, seems involved in the pathophysiology of HFpEF.
Increased epicardial fat was predictive of incidence HFpEF, but not HF with
reduced ejection fraction. In recent years we and others have demonstrated that
increased epicardial fat volume in HFpEF is associated with more left
ventricular (LV) diastolic dysfunction, higher myocardial mass, higher cardiac
filling pressures, reduced exercise capacity and increased risk of mortality
and HF hospitalization. We observed that 22% of non-obese patients with HFpEF
actually had high amount of epicardial fat and this specific group had a higher
risk of mortality and HF hospitalization compared to obese patients with less
epicardial fat volume. However, the exact mechanisms responsible for the
negative effects of epicardial fat on the heart in HFpEF remain inaccurately
defined. We hypothesize that an abundance of epicardial fat surrounding the
heart within a closed pericardial sac may constrain the heart leading to
ventricular interdependence. This phenomenon is typically present during
exercise, not at rest. More insights into the role of epicardial fat in HFpEF
are important as they may help the design of specific therapies that target
epicardial fat.
Study objective
To investigate the negative effects of epicardial fat on cardiac function,
morphology and pericardial restrain during exercise.
Study design
Investigator initiated, cross-sectional, observational cohort study.
Study burden and risks
This will be a non-invasive exercise study. The will be no vena puncture, no
invasive intervention and the patients are not exposed to any radiation and/or
contrast agents. The cardiopulmonary exercise test (CPET) is supervised by
trained personnel according to standard protocols. CPET is considered a safe
test, with the risks the same as for mild-moderate exercise. Major adverse
events including death, myocardial infarction, arrhythmia, haemodynamic
instability and orthopaedic injury are reported in study populations at a rate
of <1 to 5 per 10,000 tests. Since this is primarily a mechanistic study aimed
at understanding the negative effects of epicardial adipose tissue on the
heart, there is no direct benefit for the study participants. Better insights
into the negative effects that epicardial adipose tissue has on the heart in
HFpEF may help the design of future therapies that will potentially be of
benefit for this population.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Signs and symptoms of HF according to the Europeans Society of Cardiology
guideline.
2. LV ejection fraction >=40%.
3. HFA-PEFF score >=5 or HFA-PEFF score 2-4 in combination with positive stress
test
4. >18 years of age
5. Able to perform a bicycle exercise test
6. Willing to sign informed consent
Exclusion criteria
1. Body weight >140 kg
2. Uncontrolled atrial fibrillation or other significant arrhythmia with
resting heart rate >110 bpm during the assessment
3. Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)
4. Myocardial infarction, percutaneous coronary intervention or coronary
artery bypass graft <3 months or untreated severe obstructive coronary
artery stenosis
5. More than moderate left-sided valve disease.
6. Complex congenital heart disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80740.042.22 |