Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia (FH-FEMINA)

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Familial Hypercholesterolemia

Study type: Observational

Funder types: Other

Identifiers

NCT05367310

395816

Details and patient eligibility

About

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.

Full description

Patients with familial hypercholesterolemia (FH) have elevated plasma levels of LDL-cholesterol from first years of life. Cholesterol burden through life defines risk of cardiovascular disease. In women with FH, cholesterol levels increase during pregnancy both due to physiological changes as well as discontinuation of cholesterol lowering medication during planning of pregnancy, during the pregnancy and during breastfeeding. Few studies on the effects of breastfeeding on lipid profile in women with FH exists. There is also limited data on whether and to what extent the cholesterol lowering statins transfer to breast milk.

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 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 FH women end breastfeeding the child and start statin treatment.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

50 participants in 2 patient groups

Women with familial hypercholesterolemia

Description:

Women with familial hypercholesterolemia

Women without hypercholesterolemia

Description:

Women without hypercholesterolemia