Status:
RECRUITING
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Society for Maternal-Fetal Medicine Foundation
American Association of Obstetricians and Gynecologists Foundation
Conditions:
Gestational Hypertension
Hypertension in Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduc...
Eligibility 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)
Key Trial Info
Start Date :
March 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06785116
Start Date
March 2 2025
End Date
August 1 2028
Last Update
March 4 2026
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109