The main goal of this study is to explore the pattern of physiologic and pathophysiologic cardiac recovery after a preeclamptic pregnancy compared to a normotensive pregnancy, up till 18 months PP.To study the link between placental acute atherosis…
ID
Source
Brief title
Condition
- Heart failures
- Pregnancy, labour, delivery and postpartum conditions
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The pattern of cardiac recovery (in terms of cardiac geometry, function and
miRNA expression) after a preeclamptic pregnancy compared to a normotensive
pregnancy.
The relation between acute placental atherosis with subclinical coronary
atherosclerosis at 12 months pospartum
*
Secondary outcome
Lifestyle (questionnaire)
Blood Pressure
Metabolic syndrome (MetS)
Kidney function
Glycocalyx thickness (by means of the Glycocheck)
Coronary artery calcification (CAC)
Carotid Intima media thickness
Flow mediated dilation
Background summary
Pregnancy is considered a cardiovascular (CV) stress test, and complicated
pregnancies are associated with an increased risk for cardiovascular disease
(CVD) later in life. Consequently, a better understanding of cardiac adaptation
to pregnancy and cardiac recovery in the postpartum period in healthy and
complicated pregnancy, may lead to a better understanding of maternal CV health
later in life. Moreover, it is known that often the pregnancy induced CV
adaptation does not resolve completely after a short postpartum (PP) period and
it is not clear whether these induced changes will resolve over a longer period
of time (i.e. in the upcoming months/years after delivery). Understanding the
cardiac adaptation during pregnancy and the reversal process in the postpartum
period, as well as the factors that influence this these processes, may provide
us not only insight in this mechanism, but may help us in identifying factors
that may be target points for modification.
On the other hand, preecalampsia is in many cases accompanied by soft plaque
formation in the placenta, being defined as decidual vasculupathy or acute
atherosis. This process resembles the pathological foam cell formation process
in atherosclerosis that precedes coronary artery disease. As former preeclamtic
women have an up to 8 fold increased risk for coronary artery disease, studying
the link between placental acute atherosis and subclinical systemic
atherosclerosis my aid in early detection of those women at risk.
Study objective
The main goal of this study is to explore the pattern of physiologic and
pathophysiologic cardiac recovery after a preeclamptic pregnancy compared to a
normotensive pregnancy, up till 18 months PP.
To study the link between placental acute atherosis and subclinical systemic
atherosclerosis
Study design
This study is a longitudinal cohort study. The first measurement will be
performed upon admittance for induction of labour or caesarean section, which
corresponds with 48-24 hours before delivery. Further measurements will be
performed in clusters at PP intervals of: 24-48 hours, 3 weeks, 6 weeks, 3
months, 6 months, 12 months and 18 months.
If women find the frequent visits a large burden, they may choose to
participate in a short track study, meaning participating in visit 1, visit 2
and at 12 month visit 3 in order to answer our second primary objective. To
participate in the short track, they should at least be willing to enter the
study at delivery by providing their placenta for research and later the
measurement at 12 months postpartum. Therfore it is allowed for the short track
to miss the first and second measurement.
Study burden and risks
The first visit of this study will be performed while the participant is
administered for the induction of labour or caesarean section, thus an extra
visit is not necessary. This is also true for the first PP measurements. The
next 6 visits will be after the participant is discharged from the hospital and
extra visits are necessary, except for the 6 weeks PP visit, which is a routine
visit. The frequent visits may cause some discomfort, especially since our
participants are young mothers who still need to take care of their child.
During the measurement, one of our co-workers will assist in taking care of the
newborn so that the participant can bring her child with her.
Each of the visits will last approximately 2 hours in the MUMC+. The only
invasive procedure is a venapunction where 75 ml blood will be extracted. The
only unfavourable side effect can be a small hematoma (rare). Clinically,
participants will be advised based on their risk profile following standard
*cardiovasculair risicomanagement*.
Transthoracic echocardiography will be performed by qualified technicians at
the cardiovascular department at the MUMC+. Experience shows that this
investigation is not experienced as uncomfortable. All measurements will be
performed or supervised by an experienced researcher. These investigations are
already approved previously in other METC applications (CMO-nr: 2008/226;
2009/004; 10-2-066). The other measurements (questionnaires, blood pressure
(BP), weight measurement, urine collection and glycocalyx measurement) do not
cause any discomfort for the patient besides the time that it takes. On the
other hand, potential health improvement and early detection of CV risk
profiles and initiation of already existing effective prevention strategies
that improve lifestyle are important benefits.
We will start with inviting women to participate in the whole study. If they
refuse due to the burden of the frequent visits, we will ask them whether they
would be interested in a shorter study period in which they will only be
measured at diagnosis, before delivery and at 12 months postpartum. At 12
months, also a coronary CTA will be performed to assess soft plaque formation
and calcium score to answer our second objective. Besides, flow mediated
dilation (FMD) and carotid intima media thickness (IMT) will be assessed. If
they chose to participate in the complete study, they will be asked whether
they are interested in doing the additional measurement of the short track
aside as well as this will only mean that at 12 months postpartum, a CTA, IMT
and FM measurement will be performed.
The CT exams are generally painless, fast and easy. There may be some
discomfort from having to remain still for several minutes and with placement
of an IV. This will feel as a pin prick when the needle is inserted into the
vein. A warm, flushed sensation during the injection of the contrast materials
and a metallic taste in the mouth that lasts for at most a minute or two may be
experience. Besides, a sensation for urge to urinate can be felt; however, this
is actually a contrast effect and subsides quickly. A beta-blocker will be
given beforehand in order to lower the heart rate below 70 bpm so that the
lowest radiation dose can be used.
P Debeyeplein 25
Maastricht 6229 HX
NL
P Debeyeplein 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Cases consist of women (18 years or older) with preeclampsia (PE) in the
current pregnancy (PE is defined as hypertension (systolic blood pressure >= 140
mmHg and/or diastolic BP >= 90 mmHg) developed after 20 weeks of pregnancy with
de novo proteinuria (>= 300 mg/ 24 hours)), Controls are women (18 years or
older) with an uncomplicated pregnancy (i.e no foetal or maternal placental
complications, such as pregnancy induced hypertension, preeclampsia or
HELLP-syndrome, or small for gestational birth infancies)
Exclusion criteria
Cases
* Women who do not want to be informed about the results of the tests, or women
who do not
want their general practitioner and specialist(s) to be informed about
the test results
* Known allergy for iodinated contrast (only if they chose to participate in a
track including
the CTA measurement)
* Known contraindication for the use of betablockers or nitroglycerine
Controls
* Women with diabetes Mellitus and gestational diabetes
* Women with (suspected) IUGR in the current pregnancy (estimated fetal weight
p<10)
* Preterm delivery of the current pregnancy ( gestational age <37 weeks)
* Women who do not want to be informed about the results of the tests, or women
who do not
want their general practitioner and specialist(s) to be informed about
the test results
* Known allergy for iodinated contrast (only if they chose to participate in a
track including
the CTA measurement)
* Known contraindication for the use of betablockers or nitroglycerine
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 | NL52556.068.15 |