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

Familial Hypercholesterolemia Clinical Trial

— FH-FEMINA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05367310
• Other study ID #: 395816
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: Kirsten B Holven, PhD
• Phone: +4722851361
• Email: kirsten.holven[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with familial hypercholesterolemia (FH)

• Women without FH

• Above 18 years

• Are pregnant or plan pregnancy

• Both women who intend to breastfeed and those who not breastfeed

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentration of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides during breastfeeding (repeated measurements) among women with and without FH	Investigate the effect of breastfeeding on plasma 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.	Up to 12 months after delivery or end of breastfeeding period
Secondary	Change in circulating cardiovascular risk markers (e.g. change in concentration of inflammatory markers) during breastfeeding (repeated measurements) in women with and without FH	Investigate effect of breastfeeding (frequency and duration) on other CVD risk markers (e.g. inflammatory markers), measured in circulation among women with and without familial hypercholesterolemia	Up to 12 months after delivery or end of breastfeeding period
Secondary	Change in PBMC gene expression during breastfeeding (repeated measurements) in women with and without FH	Investigate effect of breastfeeding (frequency and duration) on Peripheral Blood Mononucleal Cells (PBMC) gene expression level among women with and without familial hypercholesterolemia	Up to 12 months after delivery or end of breastfeeding period
Secondary	Measurement of statin and PCSK9i concentration in breast milk before and after restarting ordinary statin and PCSK9i treatment in women with FH	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.	Repeated milk sampling up to one week after stop of breastfeeding and start of ordinary statin/PCSK9i treatment.
Secondary	Lipid (lipidomics) and metabolite profiling (metabolomics) and measurement of contaminants in breast milk samples (repeated samples) of women with and without FH	Perform lipid profiling (lipidomics) and metabolite profiling (metabolomics) and analyze contaminants in breast milk samples of women with FH and without. Breast milk samples will be collected at repeated time points through breast feeding period	Up to 12 months after delivery or end of breastfeeding period
Secondary	Concentration of total cholesterol and metabolic markers in infants of women with FH	Investigate levels of total cholesterol and other metabolic markers in infants of women with FH, at 12 months of age and at maternal re-start of ordinary treatment, using dried blood spots (DBS).	Measurement at infant age 12 months and at maternal re-start of ordinary treatment