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CAREFOL-HT Offspring

CAREFOL-HT Offspring Logo

Long-term impact of tetrahydrobiopterin availability during preeclamptic pregnancies on offspring vascular and cardiac development

Study Background

Preeclampsia is a pregnancy-related condition characterised primarily by high blood pressure. There is evidence to suggest that babies born to preeclamptic pregnancies, particularly with early-onset diagnosis (before 34 weeks gestation), have a greater risk of developing high blood pressure and cardiovascular disease later in life. Maternal supplementation with 5-MTHF may help to regulate levels of tetrahydrobiopterin (BH4), a key molecule in modulating blood vessel health that is evidenced to decline in mothers with preeclampsia and/or high blood pressure. CAREFOL-HT Offspring aims to investigate the cardiovascular structure and function of children born to normotensive and preeclamptic pregnancies and determine if BH4 pathway modification during pregnancy (via supplementation with 5-MTHF) can improve postnatal blood vessel and cardiovascular health.

Study Objectives

CAREFOL-HT Offspring will assess the cardiac structure, function and cardiovascular development of offspring born to normotensive and preeclamptic pregnancies, providing specific insight into the long-term effects of different doses of maternal 5-MTHF supplementation taken during preeclamptic pregnancies.

Study Recruitment

We are inviting back the offspring of mothers involved in the CAREFOL-HT trial, of which there were a mixture of women who had normotensive and preeclamptic pregnancies. Of the women with preeclamptic pregnancies, there were three intervention groups who were administered high-dose tetrahydrofolate (5-MTHF; 15 mg), low-dose 5-MTHF (5 mg) or a placebo. In total we will recruit 80 offspring (aged 1-4 years), with 20 from each group of mothers from CAREFOL-HT (normotensive, preeclamptic with 15 mg 5-MTHF, preeclamptic with 5 mg 5-MTHF, preeclamptic with placebo).

Study Visits

There is one study visit, lasting approximately 1 hour and 30 minutes. This visit takes place in the Cardiovascular Clinical Research Facility in the John Radcliffe Hospital, Oxford. During the visit, various non-invasive physiological and cardiovascular assessments will be performed, including anthropometrics, blood pressure, echocardiography, microvascular imaging of the ear (using VITA), and arterial stiffness (pulse wave velocity and pulse wave analysis using Vicorder). A parent/legal guardian will also complete a questionnaire about their child’s diet, health and medical history during the visit. Following this, participation in the study is completed.

Research Funding

Support for this study is provided by research funding from the British Heart Foundation.

Study Approvals

All research in the NHS is looked at by an independent group of people called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed and approved by Wales Research Ethics Committee 6 (25/WA/0308).

Contact Us

The CAREFOL-HT Offspring Study team

Email: carefol-ht@cardiov.ox.ac.uk