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

Study acronym: DAPA-HP
StatusRecruiting
PhasePhase 4
Started2025-03-02
View on ClinicalTrials.gov ↗

Amendment history

2026-03-01
minor
Study Status, Study Design v2
Enrollment target100→200
2025-03-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02→confirmed 2025-03-02
Study sitesdetails revised at 1 of 1 site
2025-01-15
minor
Original filing
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.
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