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Functional cardiac adaptation during and after pregnancy

Functional cardiac adaptation during and after pregnancy - Pregnancy-Induced Cardiac adaptatiON (preg-ICON).

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50433
Enrollment
100
Registered
2022-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional cardiac adaptation

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Ages between 18 * 40 years. - Healthy pregnant women. - Parity under or equal to 2 (no more than 2 previous advanced pregnancies)

Exclusion criteria

Exclusion criteria: - Complications during current pregnancy or during a previous pregnancy that may affect the current pregnancy including HELLP syndrome and pre-eclampsiaia. - Twin pregnancy. - Use of prescribed medication. - Unable to understand study procedures. - Unable or unwilling to provide informed consent.

Design outcomes

Primary

MeasureTime frame
To determine Echocardiography parameters to be obtained will include LVEF, left ventricular dimensions, left ventricular mass index, septal wall thickness, posterior wall thickness, systolic function), LV mass, left atrial (LA) volume and e*. If available, other echocardiographic parameters, including right atrial dimensions, parameters of diastolic dysfunction (i.e., E, A, E/A ratio, deceleration time, e* and E/e* ratio) and valve (dys)function will also be evaluated. - to obtain a descriptive biomarker profile of women during and after pregnancy, but especially to differentiate lactating women from non-lactating women. - Proteomics will be used to determine unbiased profiles pertaining to circulating factors in the collected blood samples

Secondary

MeasureTime frame
-The serum collected will be added to culturing conditions of in vitro models that are used as surrogates for the human heart. These models are based on cultured cardiomyocytes that have been generated from pluripotent stem cells. In these in vitro studies, gene expression, protein expression, cell size, and metabolic function will be determined as functional parameters. These cells have been obtained as part of a previous study for which ethical approval was given (METc2014/104).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)