Clinical trial NCT05367310: Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women with Familial Hypercholesterolemia
Official title: Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women with Familial Hypercholesterolemia (FH-FEMINA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Familial Hypercholesterolemia
Keywords: Breastfeeding
Cardiovascular disease
Pregnancy
Lipid profile
Women
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2022-05-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with and without familial hypercholesterolemia (FH)

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: Up to 12 months after delivery or end of breastfeeding period
Secondary outcomes:
measure: Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein (CRP).
timeFrame: Up to 12 months after delivery or end of breastfeeding period
measure: Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and metabolic markers (e.g. glucose).
timeFrame: Up to 12 months after delivery or end of breastfeeding period
measure: Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight.
timeFrame: Up to 12 months after delivery or end of breastfeeding period
measure: Investigate the breast milk composition (lipids and metabolites) throughout the breastfeeding period.
timeFrame: Up to 12 months after delivery or end of breastfeeding period
measure: Investigate the concentration of statins in the breast milk and dried blood spot of the offspring of women with FH after start of lipid-lowering medication.
timeFrame: Repeated milk sampling up to one week after start of ordinary statin treatment.
measure: Investigate the concentration of total cholesterol and metabolic markers in dried blood spots collected at 12 months postpartum in offspring of women with FH
timeFrame: Measurement at infant age 12 months
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University
city: Rotterdam
country: Netherlands
facility: Department of Internal Medicine, Erasmus MC Cardiovascular Institute
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kirsten Holven, PhD
role: PRINCIPAL_INVESTIGATOR
References: