Gestational HypertensionPhase 4DAPA-HPNCT06785116
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Gestational Hypertension and Hypertension in Pregnancy, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Hypertension, Hypertension in Pregnancy, Pre-Eclampsia
- What is being tested?
- Dapagliflozin 10mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2025to Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Levi Anderson, 734-763-0295, levijand@umich.edu
Ashley Hesson, MD, PhD
About this study
Official title: 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.
- Conditions
- Gestational Hypertension, Hypertension in Pregnancy, Pre-Eclampsia, Superimposed Pre-Eclampsia, Cardiovascular Complication
- Being tested
- Placebo, Dapagliflozin 10mg Tab
- Keywords
- Medication, Placebo, Postpartum period, Cardiovascular risk reduction, Echocardiogram
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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 TabDrug
Also called Farxiga
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dapagliflozin | Experimental | 10 Milligram (mg) orally Receives: Drug: Dapagliflozin 10mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Secondary outcomes (6)
The number of patients screened
Measured: 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).
Measured: 2-year recruitment period
Reasons for ineligibility and refusal to participate
Measured: 2-year recruitment period
Patient-stated adherence
This will be collected by the patient medication diary and study visit questionnaire.
Measured: baseline to 6 months
Patient reported barriers to adherence
Participants will answer 2 questions regarding missed doses of medications. These will be summarized.
Measured: baseline to 6 months
Loss to follow-up rates
Information on loss to follow-up (where available) will be reported to inform future work.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start2 Mar 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted in a 1:1 fashion between the DAPA Group and the Control Group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Maternal-Fetal Medicine Foundation, American Association of Obstetricians and Gynecologists Foundation
- Responsible party
- Principal investigator, Ashley Hesson, University of Michigan
- Investigators
- Ashley Hesson, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785116
- Sponsor's protocol ID
- HUM00260815
- Acronym
- DAPA-HP
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies
- ClinicalTrials.gov ID
- NCT06785116
- Acronym / sponsor ID
- DAPA-HP / HUM00260815
- Conditions
- Gestational Hypertension, Hypertension in Pregnancy, Pre-Eclampsia, Superimposed Pre-Eclampsia, Cardiovascular Complication
- Keywords
- Medication, Placebo, Postpartum period, Cardiovascular risk reduction, Echocardiogram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Society for Maternal-Fetal Medicine Foundation, American Association of Obstetricians and Gynecologists Foundation
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be conducted in a 1:1 fashion between the DAPA Group and the Control Group.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg Tab10 Milligram (mg) orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants 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 | Placebo |
| Dapagliflozin 10mg TabAlso: FarxigaParticipants 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 |
Primary outcome
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.
6 secondary outcomes
The number of patients screened
Time frame: 2-year recruitment period
The number of patients screen-outs vs screen-ins
Time frame: 2-year recruitment period
Reasons for ineligibility and refusal to participate
Time frame: 2-year recruitment period
Patient-stated adherence
Time frame: baseline to 6 months
Patient reported barriers to adherence
Time frame: baseline to 6 months
Loss to follow-up rates
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Hesson, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Gestational Hypertension and Hypertension in Pregnancy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Levi Anderson (734-763-0295, levijand@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk reduction score (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.