Functional cardiac adaptation during and after pregnancy

Withdrawn

• Conditions: Functional cardiac adaptation; 10010273

• Registration Number: NL-OMON50433
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 100

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

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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