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Recruiting Phase 4 NCT06785116

A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)

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Trial Parameters

Condition Gestational Hypertension
Sponsor University of Michigan
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 200
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-03-02
Completion 2028-08
Interventions
PlaceboDapagliflozin 10mg Tab

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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 reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery. Eligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group). The study hypothesizes: The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.

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 pre

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