NCT05367310Active, not recruiting
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia (FH-FEMINA)
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
The study aims to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH) compared to women without FH. Women with FH will be recruited in Norway, the Netherlands, and the Czech Republic. Women without FH will be recruited in Norway. Women with and without FH who are pregnant or planning pregnancy will be recruited, and will be invited to repeated study visits from the end of pregnancy and through the first year after delivery. Blood samples and data on anthropometry, health, pregnancy, lifestyle and diet will be collected. Statin transfer into breast milk will also be measured in breast milk samples collected when the women end breastfeeding the child and start statin treatment.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 30 Apr 2022
- Start date
- 1 May 2022
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Oslo University Hospital
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05367310
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 May 2022 to the primary completion date, 31 Aug 2026
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- a history of ASCVD.
Other
- Not filling the inclusion criteria.
- known pre-pregnancy hypercholesterolemia,
Who the study is looking for
- age 18 years or older,
- confirmed diagnosis of FH through genetic testing or clinical assessment based on the Dutch Lipid Clinic Network,
- singleton pregnancy in the third trimester,
- a sufficient command of Norwegian, Dutch, Czech or English language.
- age 18 years or older,
- singleton pregnancy in the third trimester,
- a sufficient command of Norwegian or English language.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre of Cardiovascular Surgery and Transplantation Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Department of Internal Medicine, Erasmus MC Cardiovascular Institute Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
Related publications
- Extensive pregnancy-related off-treatment time in women with familial hypercholesterolaemia.Atherosclerosis · 2026 · PMID 41740525
This page is information, not medical advice. Discuss any trial with your doctor.