Could a common diabetes pill protect new Moms' hearts?
NCT ID NCT06785116
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if dapagliflozin, a diabetes drug, can reduce heart and blood vessel risks in women who had high blood pressure during pregnancy. About 200 participants will take either the drug or a placebo daily for six months after delivery. The goal is to see if the drug improves blood pressure, weight, and heart function, potentially preventing future heart problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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