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New treatment option for Gestational Hypertension
Official title A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
ClinicalTrials.gov ID: NCT06785116
What this study is testing
What is Dapagliflozin 10mg Tab?
Dapagliflozin 10mg Tab is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for gestational hypertension.
Also referred to as Farxiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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...
- Consents to participation and must understand/read/speak English with the ability to understand and willingness to sign a written informed consent in...
- 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
You likely can't join 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)
See the full eligibility 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.