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

NCT06785116 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HUM00260815
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The number of patients screened

  2-year recruitment period

• The number of patients screen-outs vs screen-ins

  2-year recruitment period

• Reasons for ineligibility and refusal to participate

  2-year recruitment period

• Patient-stated adherence

  baseline to 6 months

• Patient reported barriers to adherence

  baseline to 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Dapagliflozin

EXPERIMENTAL

10 Milligram (mg) orally

Drug: Dapagliflozin 10mg Tab

Interventions

Placebo DRUG

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.

Placebo

Dapagliflozin 10mg Tab DRUG

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.

Also known as: Farxiga

Dapagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• Society for Maternal-Fetal Medicine Foundation: collaborator
• American Association of Obstetricians and Gynecologists Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ashley Hesson, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Levi Anderson

CONTACT

734-763-0295; levijand@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the clinical team, and researchers will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Model Details: The study will be conducted in a 1:1 fashion between the DAPA Group and the Control Group.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 21, 2025
• Study Start: March 2, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)