Familial HypercholesterolemiaFH-FEMINANCT05367310
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia
An observational study of Familial Hypercholesterolemia, run by Oslo University Hospital at 4 sites in 3 countries.
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 FH will be recruited in Norway, the Netherlands, and the Czech Republic. Women without FH will be recruited in Norway. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Familial Hypercholesterolemia
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 May 2022to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with and without familial hypercholesterolemia (FH)
Who may be able to join
- 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.
- age 18 years or older,
- singleton pregnancy in the third trimester,
- a sufficient command of Norwegian or English language.
Who cannot join
- Not filling the inclusion criteria.
- known pre-pregnancy hypercholesterolemia,
- a history of ASCVD.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Czechia2 sites
Centre of Cardiovascular Surgery and Transplantation
Brno
Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University
Prague
Netherlands1 site
Department of Internal Medicine, Erasmus MC Cardiovascular Institute
Rotterdam
About this study
Official title: Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia (FH-FEMINA)
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.
Read the 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.
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Breastfeeding, Cardiovascular disease, Pregnancy, Lipid profile, Women
- Medical subject headings
- Hyperlipoproteinemia Type II, Breast Feeding, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with familial hypercholesterolemia | Women with familial hypercholesterolemia | |
| Women without hypercholesterolemia | Women without hypercholesterolemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: Up to 12 months after delivery or end of breastfeeding period
Secondary outcomes (6)
Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein (CRP).
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).
Measured: Up to 12 months after delivery or end of breastfeeding period
Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and metabolic markers (e.g. glucose).
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.
Measured: Up to 12 months after delivery or end of breastfeeding period
Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight.
Investigate the association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight in women with and without familial hypercholesterolemia.
Measured: Up to 12 months after delivery or end of breastfeeding period
Investigate the breast milk composition (lipids and metabolites) throughout the 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
Measured: Up to 12 months after delivery or end of breastfeeding period
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.
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.
Measured: Repeated milk sampling up to one week after start of ordinary statin treatment.
Investigate the concentration of total cholesterol and metabolic markers in dried blood spots collected at 12 months postpartum in offspring of women with FH
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).
Measured: Measurement at infant age 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 May 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Kirsten Bjørklund Holven, Oslo University Hospital
- Investigators
- Kirsten Holven, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367310
- Sponsor's protocol ID
- 395816
- Acronym
- FH-FEMINA
- Status last verified
- Feb 2026
- First submitted
- 30 Apr 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klevmoen M, van Lennep JR, Bogsrud MP, Vesterbekkmo EK, Pedersen EKR, Hovland A, Mulder JWCM, Brekke HK, Iversen PO, Vaclova M, Vrablik M, Freiberger T, Retterstol K, Holven KB. Extensive pregnancy-related off-treatment time in women with familial hypercholesterolaemia. Atherosclerosis. 2026 Apr;415:120668. doi: 10.1016/j.atherosclerosis.2026.120668. Epub 2026 Feb 19.
PubMed 41740525Klevmoen M, Mulder JWCM, Bogsrud MP, Retterstol K, Vesterbekkmo EK, Pedersen EKR, Freiberger T, Vrablik M, Vaclova M, Hovland A, Vethe NT, Brekke HK, Iversen PO, Veierod M, Roeters van Lennep J, Holven KB. Prospective study on breastfeeding, lipid profile and cardiovascular risk markers in women with familial hypercholesterolaemia: study protocol for the FH-FEMINA study. BMJ Open. 2025 Apr 27;15(4):e092208. doi: 10.1136/bmjopen-2024-092208.
PubMed 40288796
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia (FH-FEMINA)
- ClinicalTrials.gov ID
- NCT05367310
- Acronym / sponsor ID
- FH-FEMINA / 395816
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Breastfeeding, Cardiovascular disease, Pregnancy, Lipid profile, Women
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with familial hypercholesterolemia | – | –Women with familial hypercholesterolemia |
| Women without hypercholesterolemia | – | –Women without hypercholesterolemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with and without familial hypercholesterolemia (FH)
Key inclusion criteria (7 listed)
- 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.
- age 18 years or older,
Key exclusion criteria (3 listed)
- Not filling the inclusion criteria.
- known pre-pregnancy hypercholesterolemia,
- a history of ASCVD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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
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
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 breast milk composition (lipids and metabolites) throughout the breastfeeding period.
Time frame: Up to 12 months after delivery or end of breastfeeding period
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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 41740525Klevmoen M, van Lennep JR, Bogsrud MP, Vesterbekkmo EK, Pedersen EKR, Hovland A, Mulder JWCM, Brekke HK, Iversen PO, Vaclova M, Vrablik M, Freiberger T, Retterstol K, Holven KB. Extensive pregnancy-related off-treatment time in women with familial hypercholesterolaemia. Atherosclerosis. 2026 Apr;415:120668. doi: 10.1016/j.atherosclerosis.2026.120668. Epub 2026 Feb 19.
- Derived from this study: PubMed 40288796Klevmoen M, Mulder JWCM, Bogsrud MP, Retterstol K, Vesterbekkmo EK, Pedersen EKR, Freiberger T, Vrablik M, Vaclova M, Hovland A, Vethe NT, Brekke HK, Iversen PO, Veierod M, Roeters van Lennep J, Holven KB. Prospective study on breastfeeding, lipid profile and cardiovascular risk markers in women with familial hypercholesterolaemia: study protocol for the FH-FEMINA study. BMJ Open. 2025 Apr 27;15(4):e092208. doi: 10.1136/bmjopen-2024-092208.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Holven, PhD principal investigator
Oslo University Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypercholesterolemia, run by Oslo University Hospital at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Up to 12 months after delivery or end of breastfeeding period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.