Clinical Trial

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

Study acronym: DAPA-HP
Recruiting Phase 4
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-15; most recent amendment 2026-03-01.
Status change: Not Yet Recruiting → Recruiting 2025-03-06
Trial Details
NCT Number NCT06785116
Lead Sponsor University of Michigan
Collaborators: Society for Maternal-Fetal Medicine Foundation, American Association of Obstetricians and Gynecologists Foundation
Conditions Gestational Hypertension, Hypertension in Pregnancy, Pre-Eclampsia, Superimposed Pre-Eclampsia, Cardiovascular Complication
Enrollment 200 participants
Start Date 2025-03-02
Primary Completion 2028-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-04