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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia; Hypertension in Pregnancy; Gestational Hypertension; Cardiovascular Complication; Superimposed Pre-Eclampsia
• Intervention / Treatment: Drug: Placebo; Drug: Dapagliflozin 10mg Tab

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Levi Anderson; Phone Number: 734-763-0295; Email: levijand@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Levi Anderson; Phone Number: 734-763-0295; Email: levijand@umich.edu
      • Principal Investigator: Ashley Hesson, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: 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.
Experimental: Dapagliflozin; 10 Milligram (mg) orally	Drug: 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.; Other Names: Farxiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk reduction score	The score will be summed and compared between groups.The components with outcome-based binary assessments by the following: Biometric: change in systolic blood pressure (scores of 0 or 1) and change in body weight (scores of 0 or 1); Echocardiogram: change in left ventricle wall thickness (scores of 0 or 1) and change in left ventricle mass (scores of 0 or 1); Clinical: Non-hospitalization (scores of 0 or 1) and return to baseline antihypertensive needs (scores of 0 or 1) The total scores range from 0-6 with a higher score indicating greater cardiovascular risk reduction.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients screened		2-year recruitment period
The number of patients screen-outs vs screen-ins	These will be the participants that qualify either by blood pressure or laboratory parameter (BNP) (screen-ins) or if not eligible (screen-outs).	2-year recruitment period
Reasons for ineligibility and refusal to participate		2-year recruitment period
Patient-stated adherence	This will be collected by the patient medication diary and study visit questionnaire.	baseline to 6 months
Patient reported barriers to adherence	Participants will answer 2 questions regarding missed doses of medications. These will be summarized.	baseline to 6 months
Loss to follow-up rates	Information on loss to follow-up (where available) will be reported to inform future work.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Society for Maternal-Fetal Medicine Foundation; American Association of Obstetricians and Gynecologists Foundation
• Investigators: Principal Investigator: Ashley Hesson, MD, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 21, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular risk reduction; Placebo; Echocardiogram; Medication; Postpartum period
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; dapagliflozin
• Other Study ID Numbers: HUM00260815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No