Recruiting

DAPAgliflozin

Sponsor:

University of Michigan

Code:

NCT06785116

Conditions

Gestational Hypertension

Hypertension in Pregnancy

Pre-Eclampsia

Superimposed Pre-Eclampsia

Cardiovascular Complication

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo

Dapagliflozin 10mg Tab

Study Details

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.

Conditions

Gestational Hypertension

Hypertension in Pregnancy

Pre-Eclampsia

Superimposed Pre-Eclampsia

Cardiovascular Complication

Study ID

NCT06785116

Start date

Mar 2, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

experimental: Dapagliflozin

10 Milligram (mg) orally

Interventions

Placebo

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.

Dapagliflozin 10mg Tab

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.

Primary outcome measure

  • Cardiovascular risk reduction score [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Levi Anderson

734-763-0295levijand@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Levi Anderson

734-763-0295levijand@umich.edu

Principal Investigator:

Ashley Hesson, MD, PhD

More Information

Sponsor

University of Michigan

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Medication
  • Placebo
  • Postpartum period
  • Cardiovascular risk reduction
  • Echocardiogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-03-04.