Using dapagliflozin to reduce cardiovascular risk after hypertensive pregnancies
A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies
This study is testing if the medication dapagliflozin can help reduce heart risks for women who had high blood pressure during pregnancy after they give birth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06785116 on ClinicalTrials.gov |
What this trial studies
This pilot-scale, randomized, placebo-controlled trial aims to evaluate the feasibility, acceptability, and efficacy of dapagliflozin in reducing cardiovascular risks during the postpartum period for women who experienced hypertensive pregnancies. Participants will be randomly assigned to receive either dapagliflozin (10mg daily) or a placebo for six months. The study focuses on women at high risk of adverse cardiovascular outcomes within five years post-delivery, assessing their cardiovascular risk reduction scores compared to the control group.
Who should consider this trial
Good fit: Ideal candidates are women who have delivered at the University of Michigan and have been diagnosed with a hypertensive pregnancy.
Not a fit: Patients who do not have a history of hypertensive pregnancies or those who are not fluent in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower cardiovascular risks for women who have had hypertensive pregnancies.
How similar studies have performed: Other studies have shown promise in using similar medications for cardiovascular risk reduction, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted for delivery at the University of Michigan (UM) Labor and Delivery (L\&D) unit or enrolled in the UM postpartum blood pressure monitoring program following a delivery at the UM L\&D unit * Determined to be at least 23 and 0/7 weeks of gestation based on a clinically acceptable dating method (can be a single or multifetal gestation with or without the presence of fetal anomalies) at the time of delivery * Consents to participation and must understand/read/speak English with the ability to understand and willingness to sign a written informed consent in English * Diagnosed with a hypertensive pregnancy by either of the following criteria: * Taking an antihypertensive medication for the diagnosis of chronic or essential hypertension at the time of admission * Hypertension, chronic hypertension, or essential hypertension must be present in the prospective participant's medical record * Antihypertensive" can be any medication taken for the purpose of blood pressure control per the medical record * A documented hypertensive disorder of pregnancy (gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, or eclampsia) prior to delivery * Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document. * Has two or more blood pressures ≥160/110 Millimeters of mercury (mmHg) at least 60 minutes apart * If an admitted patient does not meet this blood pressure criterion but is otherwise eligible, participants can consent to have a BNP drawn within 12 hours of delivery as an alternative measure of cardiovascular risk (if the brain natriuretic peptide (BNP) is ≥100 Picograms per milliliter (pg/ml), participants are eligible to participate) Exclusion Criteria: * Non-English speaking * Ongoing pregnancy * Stated desire to become pregnant within 8 months post-delivery * Intention to breastfeed after enrollment * BNP ≥1000 pg/ml within 12 hours of delivery, clinical team to be notified of result * Comorbidities that may affect cardiovascular risk assessment (per protocol) * Contraindication to dapagliflozin (per protocol)
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Ashley Hesson, MD, PhD — University of Michigan
- Study coordinator: Levi Anderson
- Email: levijand@umich.edu
- Phone: 734-763-0295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.