A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
NCT ID: NCT06785116
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-03-02
2028-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
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
10 Milligram (mg) orally
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Society for Maternal-Fetal Medicine Foundation
UNKNOWN
American Association of Obstetricians and Gynecologists Foundation
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Ashley Hesson
Assistant Professor of Obstetrics and Gynecology
Principal Investigators
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Ashley Hesson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00260815
Identifier Type: -
Identifier Source: org_study_id
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