Investigating breastfeeding's impact on cholesterol levels in women with familial hypercholesterolemia
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women with Familial Hypercholesterolemia (FH-FEMINA)
This study is testing how breastfeeding affects cholesterol levels and heart health in women with familial hypercholesterolemia compared to those without the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 3 sites (Prague and 2 other locations) |
| Trial ID | NCT05367310 on ClinicalTrials.gov |
What this trial studies
This study examines how breastfeeding affects lipid profiles and cardiovascular risk markers in women diagnosed with familial hypercholesterolemia (FH) compared to those without FH. Women who are pregnant or planning pregnancy will be recruited from Norway, the Netherlands, and the Czech Republic, and will participate in multiple study visits from late pregnancy through the first year postpartum. Blood samples and data on health, lifestyle, and diet will be collected, along with measurements of statin transfer into breast milk. The goal is to better understand the implications of breastfeeding on cholesterol management in women with FH.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older who are pregnant or planning pregnancy, with a confirmed diagnosis of familial hypercholesterolemia or without any history of hypercholesterolemia.
Not a fit: Patients who have known pre-pregnancy hypercholesterolemia or a history of atherosclerotic cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into managing cholesterol levels and cardiovascular risks in women with familial hypercholesterolemia during and after pregnancy.
How similar studies have performed: Limited studies have explored the effects of breastfeeding on lipid profiles in women with familial hypercholesterolemia, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for women with FH: 1. age 18 years or older, 2. confirmed diagnosis of FH through genetic testing or clinical assessment based on the Dutch Lipid Clinic Network, 3. singleton pregnancy in the third trimester, 4. a sufficient command of Norwegian, Dutch, Czech or English language. Exclusion Criteria for women with FH: * Not filling the inclusion criteria. Inclusion Criteria for women without FH: 1. age 18 years or older, 2. singleton pregnancy in the third trimester, 3. a sufficient command of Norwegian or English language. Exclusion Criteria for women without FH: 1. known pre-pregnancy hypercholesterolemia, 2. a history of ASCVD.
Where this trial is running
Prague and 2 other locations
- Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University — Prague, Czech Republic (Recruiting)
- Department of Internal Medicine, Erasmus MC Cardiovascular Institute — Rotterdam, Netherlands (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Kirsten Holven, PhD — Oslo University Hospital
- Study coordinator: Kirsten B Holven, PhD
- Email: kirsten.holven@medisin.uio.no
- Phone: +4722851361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.