Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia

NCT05367310 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Oslo University Hospital

Phase

Observational

Started

2022-05-01

Last updated

2026-02-05

Condition(s) studied

Familial Hypercholesterolemia

Study summary

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Change in serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides, lipoprotein(a)) from 2-4 weeks postpartum up to 12 months postpartum (absolute and relative change). — Up to 12 months after delivery or end of breastfeeding period
Investigate the change in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) in women with and without familial hypercholesterolemia, by blood sampling at repeated time points during breastfeeding period.

Trial sites (4)

Facility	City	Region
Centre of Cardiovascular Surgery and Transplantation	Brno	Czechia
Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University	Prague	Czechia
Department of Internal Medicine, Erasmus MC Cardiovascular Institute	Rotterdam	Netherlands
Oslo University Hospital	Oslo	Norway

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05367310 on ClinicalTrials.gov ↗ ← All trials in the Netherlands