NCT06785116 · University of Michigan
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
(DAPA-HP)
What this study is about
This trial is a pilot-scale, single institution randomly assigned, compared against an inactive treatment trial to assess the feasibility, acceptability, and effectiveness 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.
View original scientific description
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.
Interventions
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.
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Ann Arbor, Michigan
Collaborators
Society for Maternal-Fetal Medicine Foundation, American Association of Obstetricians and Gynecologists Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations