FH-FEMINA: Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia
Study Details
Study Description
Brief Summary
The study aims to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH). Women with 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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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). Women with 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Change in plasma concentration of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides during breastfeeding (repeated measurements) among women with FH [Up to 12 months after delivery or end of breastfeeding period]
Investigate the effect of breastfeeding on plasma lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) in women with familial hypercholesterolemia, by blood sampling at repeated time points during breastfeeding period.
Secondary Outcome Measures
- Change in circulating cardiovascular risk markers (e.g. change in concentration of inflammatory markers) during breastfeeding (repeated measurements) in women with FH [Up to 12 months after delivery or end of breastfeeding period]
Investigate effect of breastfeeding (frequency and duration) on other CVD risk markers (e.g. inflammatory markers), measured in circulation among women with familial hypercholesterolemia
- Change in PBMC gene expression during breastfeeding (repeated measurements) in women with FH [Up to 12 months after delivery or end of breastfeeding period]
Investigate effect of breastfeeding (frequency and duration) on Peripheral Blood Mononucleal Cells (PBMC) gene expression level among women with familial hypercholesterolemia
- Measurement of statin and PCSK9i concentration in breast milk before and after restarting ordinary statin and PCSK9i treatment in women with FH [Repeated milk sampling up to one week after stop of breastfeeding and start of ordinary statin/PCSK9i treatment.]
Investigate if and to what extent statin (HMG-CoA reductase inhibitors) (e.g. atorvastatin, rosuvastatin) and PCSK9i (e.g. alirocumab and evolocumab) transfer into breast milk. Breast milk samples will be collected when the women stop breastfeeding and re-start ordinary treatment.
- Lipid (lipidomics) and metabolite profiling (metabolomics) and measurement of contaminants in breast milk samples (repeated samples) of women with FH [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. Breast milk samples will be collected at repeated time points through breast feeding period
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women with familial hypercholesterolemia (FH)
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Above 18 years
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Are pregnant or plan pregnancy
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Both women who intend to breastfeed and those who not breastfeed
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oslo University Hospital | Oslo | Norway |
Sponsors and Collaborators
- Oslo University Hospital
- University of Oslo
Investigators
- Principal Investigator: Kirsten Holven, PhD, Oslo University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 395816