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NCT Number: NCT06785116

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

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.

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Key information

Conditions

Gestational Hypertension Cardiovascular Complication Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension in Pregnancy Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Superimposed Pre-Eclampsia Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Ashley Hesson, MD, PhD

PRINCIPAL_INVESTIGATOR

Levi Anderson

CONTACT

[email protected]

734-763-0295

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Other names: Farxiga

Primary outcomes

  1. Cardiovascular risk reduction score

    Time frame: Baseline, 6 months

    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.

Secondary outcomes

  1. The number of patients screened

    Time frame: 2-year recruitment period

  2. The number of patients screen-outs vs screen-ins

    Time frame: 2-year recruitment period

    These will be the participants that qualify either by blood pressure or laboratory parameter (BNP) (screen-ins) or if not eligible (screen-outs).

  3. Reasons for ineligibility and refusal to participate

    Time frame: 2-year recruitment period

  4. Patient-stated adherence

    Time frame: baseline to 6 months

    This will be collected by the patient medication diary and study visit questionnaire.

  5. Patient reported barriers to adherence

    Time frame: baseline to 6 months

    Participants will answer 2 questions regarding missed doses of medications. These will be summarized.

  6. Loss to follow-up rates

    Time frame: Baseline to 6 months

    Information on loss to follow-up (where available) will be reported to inform future work.

Study contacts

Contact information is provided by the study sponsor or research team.

Levi Anderson

CONTACT

[email protected]

734-763-0295

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Association of Obstetricians and Gynecologists Foundation
  • Society for Maternal-Fetal Medicine Foundation

Registry information

Official study title

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

Acronym: DAPA-HP

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 21, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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