Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Apr 27;15(4):e092208.
doi: 10.1136/bmjopen-2024-092208.

Prospective study on breastfeeding, lipid profile and cardiovascular risk markers in women with familial hypercholesterolaemia: study protocol for the FH-FEMINA study

Marianne Klevmoen #  1   2 , Janneke W C M Mulder #  3 , Martin P Bogsrud  4 , Kjetil Retterstøl  2   5 , Elisabeth K Vesterbekkmo  6 , Eva K R Pedersen  7   8 , Tomas Freiberger  9   10   11 , Michal Vrablik  12 , Martina Vaclova  11   12 , Anders Hovland  13 , Nils Tore Vethe  14   15 , Hilde Kristin Brekke  2 , Per Ole Iversen  2   16 , Marit Veierød  17 , Jeanine Roeters van Lennep  3 , Kirsten B Holven  18   2
Affiliations

Prospective study on breastfeeding, lipid profile and cardiovascular risk markers in women with familial hypercholesterolaemia: study protocol for the FH-FEMINA study

Marianne Klevmoen et al. BMJ Open. .

Abstract

Introduction: Early and lifelong treatment is essential in patients with familial hypercholesterolaemia (FH) due to genetically elevated low-density lipoprotein cholesterol (LDL-C) from the first years of life. In women with FH, lipid-lowering treatment is interrupted during childbearing years due to contraindication of the medication during conception, pregnancy and breastfeeding. However, little is known about the impact of breastfeeding on lipid profile and other risk markers for atherosclerotic cardiovascular disease (ASCVD) in women with FH compared with women without hypercholesterolaemia, and to what extent statins transfer into breast milk.We aim to investigate (1) the association between breastfeeding and serum lipid profile in women with and without FH; (2) the association between breastfeeding and other ASCVD risk markers in women with and without FH and (3) the concentration of statins in breast milk of women with FH.

Methods and analysis: FH-FEMINA is a prospective study aiming to include 50 women with FH in Norway, the Netherlands and the Czech Republic. Additionally, 20 women without hypercholesterolaemia will be enrolled as a control group in Norway. Women will be included at the first study visit in gestational week 36, and follow-up visits will be scheduled at 2-4 weeks, and at 3, 6, 9 and 12 months postpartum. Information on lifestyle factors, treatment history and current and previous pregnancies will be collected. At each visit, a non-fasting blood sample, breast milk sample and information on diet, body mass index and blood pressure will be collected. Additional blood samples will be collected from the women with FH at 2, 4, 5, 7, 8, 10 and 11 months postpartum for as long as they are breastfeeding. At (re-)initiation of statin treatment, breast milk samples from women with FH will be collected for drug concentration measurements.

Ethics and dissemination: Ethical approval will be obtained prior to study start in all three countries. Participants will be informed about the study and receive ample time to ask questions before the informed consent form is signed. The findings from this study will be disseminated to healthcare professionals, researchers and patients via peer-reviewed scientific article(s), conferences, patient organisations and social media.

Trial registration number: NCT05367310.

Keywords: Cardiovascular Disease; Coronary heart disease; Maternal medicine; Postpartum Women; Primary Prevention.

PubMed Disclaimer

Conflict of interest statement

Competing interests: The work of JWCMM is supported by the Dutch Heart Foundation (grant number 2020B004). This funding source had no role in the writing of the manuscript. MPB has received honoraria for lectures (outside the submitted work) from Novartis, Sanofi, Amgen and Ultragenyx. KR has received lecture honoraria during the three last years from Amgen, Amarin, NovoNordic, Novartis and Sanofi. EKV has received honoraria for lectures from Amgen, Amarin, Sanofi, Novartis, Boehringer-Ingelheim and Bayer. EKRP has received speaker honoraria from Sanofi. TF received honoraria and consultancy fees from Novartis, Sanofi, Sobi and Medison, outside the submitted work. KBH has received honoraria from Sanofi (not related to the current manuscript). The other authors do not have any disclosure.

Figures

Figure 1
Figure 1. Study design. FH, familial hypercholesterolaemia.
See this image and copyright information in PMC

References

    1. Ference BA, Graham I, Tokgozoglu L, et al. Impact of Lipids on Cardiovascular Health: JACC Health Promotion Series. J Am Coll Cardiol. 2018;72:1141–56. doi: 10.1016/j.jacc.2018.06.046. - DOI - PubMed
    1. Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease: consensus statement of the European Atherosclerosis Society. Eur Heart J. 2013;34:3478–90a. doi: 10.1093/eurheartj/eht273. - DOI - PMC - PubMed
    1. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for themanagement of dyslipidaemias: lipid modification to reduce cardiovascular risk. Russ J Cardiol. 2019;25:3826. doi: 10.15829/1560-4071-2020-3826. - DOI
    1. Kaur G, Gulati M. Considerations for treatment of lipid disorders during pregnancy and breastfeeding. Prog Cardiovasc Dis. 2022;75:33–9. doi: 10.1016/j.pcad.2022.11.001. - DOI - PubMed
    1. Wiznitzer A, Mayer A, Novack V, et al. Association of lipid levels during gestation with preeclampsia and gestational diabetes mellitus: a population-based study. Am J Obstet Gynecol. 2009;201:482. doi: 10.1016/j.ajog.2009.05.032. - DOI - PMC - PubMed

Publication types

Associated data