Primary objective: Part A: MR cardiopulmonary exercise protocol validation: To validate the protocol of the CMR-ergometer against conventional ergometers in young healthy adultsPart B: CMR exercise study To examine cardiorespiratory structure and…
ID
Source
Brief title
Condition
- Heart failures
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A: MR cardiopulmonary exercise protocol validation:
The main study parameter is the increase in oxygen consumption of subjects in
relation to workload increase during a exercise test on a MR-ergometer and on a
conventional ergometer.
Part B: CMR exercise study:
The main study parameter is stroke volume of the right ventricle.
Secondary outcome
Part A: MR cardiopulmonary exercise protocol validation:
Other parameters are maximal heart frequency, CO2 production, respiratory
coefficient.
Part B: CMR exercise study:
Other study parameters are exercise capacity (peak oxygen uptake, VO2max) and
several parameters for assessment of lung function (forced expired volume in 1
second, FEV, total lung capacity, TLC, fractional residual capacity, FRC,
diffusion capacity for carbon monoxide, DLCO), and assessment of cardiac
function and structure (e.g. heart ventricular mass/volume ratio, tricuspid
regurgitation velocity, heart ventricular longitudinal strain and ejection
fraction).
Background summary
BPD is associated with a variety of long term health problems, including
cardiovascular problems and exercise intolerance. However, only a few studies
evaluate cardiovascular outcomes of BPD. In this study, we combine exercise
testing with cardiac magnetic resonance (CMR) imaging to evaluate exercise
capacity, but also to examine if exercise capacity correlates with
cardiorespiratory structure and function. We will use a MRI-compatible
ergometer (MR-ergometer). However, the exercise protocols of exercise tests
performed on the supine MR-ergometer are not yet validated against the exercise
protocols of exercise tests performed on a conventional ergometer. When well
validated, this may potentially identify a group of adolescent survivors of BPD
with an increased risk for cardiovascular events later in life, thereby
contributing disproportionately to the burden of adult cardiovascular disease
in the future. Our future perspective is to develop an exercise training
program tailored for this specific patient group.
Study objective
Primary objective:
Part A: MR cardiopulmonary exercise protocol validation:
To validate the protocol of the CMR-ergometer against conventional ergometers
in young healthy adults
Part B: CMR exercise study
To examine cardiorespiratory structure and function during submaximal exercise
in adolescent survivors of extreme prematurity with/without BPD, to potentially
reveal subtle dynamic abnormalities that are not apparent on conventional
static tests.
Secondary objectives:
1) To study the exercise capacity of adolescent survivors of extreme
prematurity with/without BPD
2) To determine if the diagnosis of BPD in the neonatal phase impose additional
impairments in exercise capacity, cardiac function and/or structure in
adolescent life
Study design
Follow-up study in Erasmus MC/ Sophia Children's Hospital, Rotterdam.
Study burden and risks
Part A: MR cardiopulmonary exercise protocol validation:
Participants need to visit the hospital twice. They will fill in a
questionnaire, and undergo two exercise tests. One on the MR-ergometer and one
on a conventional ergometer. Tests will take place on separate days, with at
least three days between tests. Participants are asked not to perform intense
physical ectivity two days before the tests.
Part B: CMR exercise study:
For the present study, patients need to visit the hospital twice. The first
visit, they will undergo a conventional cardiopulmonary exercise test (CPET)
and three pulmonary function tests. The second visit they will undergo an
echocardiogram, ECG and a CMR will be performed at rest and during exercise. In
addition, for study purposes patients need to fill in two questionnaires. For
the exercise CMR, no breath-holds or ECG gated sequences can be used. Therefore
a real-time sequence is needed. Some of these sequences are in development by
GE (investigational sequences).
For the investigational sequences such as real-time SSFP sequence (radial SSFP)
it has been verified that they do not affect the safe operation of the MRI
scanner, but they have not been validated as effective for diagnostic use. All
other sequences utilized in this study are commercially available. The
investigational sequences will be implemented on a commercially available 1.5
Tesla GE Healthcare MRI scanner. A safety declaration of GE is available.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
1. Healthy control group (n<=36; 16 for Part A, 20 for Part B); Young adults born a term at a gestational age * 37 weeks, age 18-25 years. For Part B, if possible, siblings of the participants of the preterm or BPD group are asked to participate to reduce potential lifestyle and socio-economic confounding effects.
2. Preterm group (n<=20, for Part B); Young adults born prematurely at a gestational age * 30 weeks, not diagnosed with BPD in the neonatal phase, age 18-25 years.
3. BPD group (n<=20, for Part B); Young adults born prematurely at a gestational age * 30 weeks, diagnosed with BPD in the neonatal phase, age 18-25 years. BPD is defined as oxygen dependency 28 days after birth. The severity of disease depends on the need of oxygen at 36 weeks of corrected gestational age; mild BPD no supplemental oxygen at 36-week, moderate BPD * 30% of supplemental oxygen, and severe BPD mechanical ventilation and/or oxygen >30 %.
Exclusion criteria
- Known acquired or congenital hemodynamically significant heart disease (except heart disease as a consequence of pulmonary hypertension)
- Pulmonary disorders other than BPD
- Kidney disorders
- Neurodevelopmental disabilities that would prevent cooperation with CPET and/or CMR imaging.
- Absence of written informed consent
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 | NL56898.078.16 |