RecruitingPhase 4NCT06785116

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

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

Sponsor

University of Michigan

Enrollment

200 participants

Start Date

Mar 2, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Complication Pre-Eclampsia Gestational Hypertension Hypertension in Pregnancy Superimposed Pre-Eclampsia

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a diabetes and heart medication called dapagliflozin (a type of SGLT2 inhibitor) can reduce cardiovascular risk in women who had high blood pressure during pregnancy. High blood pressure in pregnancy is a known risk factor for heart disease later in life. **You may be eligible if...** - You recently gave birth at the University of Michigan and had high blood pressure during pregnancy - You are at least 23 weeks pregnant at delivery - You are enrolled in the postpartum blood pressure monitoring program - You can read and speak English **You may NOT be eligible if...** - You did not deliver at the University of Michigan - You did not have high blood pressure during pregnancy - You have conditions that make SGLT2 inhibitors unsafe - You are unable to provide written informed consent in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Participants will take this daily for 6-months. Additionally, during the study participants will have 4 study visits and be asked to complete study specific activities (i.e. daily blood pressure, weekly weights, laboratory draws, echocardiograms, etc.) Participants will be followed remotely for 1-month after the 6-month visit.

DRUGDapagliflozin 10mg Tab