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NCT Number: NCT05367310

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Familial Hypercholesterolemia Behavior Breast Feeding Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Feeding Behavior Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre of Cardiovascular Surgery and Transplantation, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for women with FH:

  • 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.

Exclusion criteria

for women with FH:

  • Not filling the inclusion criteria.

Inclusion criteria

for women without FH:

  • age 18 years or older,
  • singleton pregnancy in the third trimester,
  • a sufficient command of Norwegian or English language.

Exclusion criteria

for women without FH:

  • known pre-pregnancy hypercholesterolemia,
  • a history of ASCVD.

Treatment and study plan

Primary outcomes

  1. 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).

    Time frame: 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.

Secondary outcomes

  1. Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein (CRP).

    Time frame: Up to 12 months after delivery or end of breastfeeding period

    Investigate the association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein) in women with and without familial hypercholesterolemia. Measurements will be performed in both plasma/serum and in peripheral blood mononuclear cells (PBMC) (gene expression levels).

  2. Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and metabolic markers (e.g. glucose).

    Time frame: Up to 12 months after delivery or end of breastfeeding period

    Investigate the association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and metabolic markers (e.g. glucose) in women with and without familial hypercholesterolemia. Measurements will be performed in both plasma/serum.

  3. Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight.

    Time frame: Up to 12 months after delivery or end of breastfeeding period

    Investigate the association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight in women with and without familial hypercholesterolemia.

  4. Investigate the breast milk composition (lipids and metabolites) throughout the breastfeeding period.

    Time frame: Up to 12 months after delivery or end of breastfeeding period

    Perform lipid profiling (lipidomics) and metabolite profiling (metabolomics) and analyze contaminants in breast milk samples of women with FH and without FH. Breast milk samples will be collected at repeated time points through breast feeding period

  5. 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.

    Time frame: Repeated milk sampling up to one week after start of ordinary statin treatment.

    Investigate the concentration of statin (HMG-CoA reductase inhibitors) (e.g. atorvastatin, rosuvastatin) in breast milk and dried blood spot of the offspring, if possible when the women re-start ordinary treatment. Fewer samples are expected from this time point, as it may be challenging to synchronize the initiation of lipid-lowering treatment with the end of breastfeeding.

  6. Investigate the concentration of total cholesterol and metabolic markers in dried blood spots collected at 12 months postpartum in offspring of women with FH

    Time frame: Measurement at infant age 12 months

    Investigate the concentration of total cholesterol and other metabolic markers in infants of women with FH, at 12 months of age, using dried blood spots (DBS).

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Acronym: FH-FEMINA

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 10, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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