Using dapagliflozin to reduce cardiovascular risk after hypertensive pregnancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot-scale, randomized, placebo-controlled trial aims to evaluate the feasibility, acceptability, and efficacy of dapagliflozin in reducing cardiovascular risks during the postpartum period for women who experienced hypertensive pregnancies. Participants will be randomly assigned to receive either dapagliflozin (10mg daily) or a placebo for six months. The study focuses on women at high risk of adverse cardiovascular outcomes within five years post-delivery, assessing their cardiovascular risk reduction scores compared to the control group.

Why it matters

Who can join: the full rules

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 it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Ashley Hesson, MD, PhD — University of Michigan
• Study coordinator: Levi Anderson
• Email: levijand@umich.edu
• Phone: 734-763-0295

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.