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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

University of Michigan

Ann Arbor, Michigan, United States, 48109