A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)

Launched by UNIVERSITY OF MICHIGAN · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called dapagliflozin can help reduce the risk of heart problems in women who have high blood pressure during pregnancy, specifically in the time after they give birth. The trial is looking for women who have been diagnosed with conditions like gestational hypertension or pre-eclampsia, which can increase the chance of future heart issues. Eligible participants will be randomly assigned to either receive dapagliflozin or a placebo (a harmless pill that looks like the medication but has no active ingredients) for six months.

To qualify for the study, women must have given birth at the University of Michigan and be at least 23 weeks pregnant at the time of delivery. They also need to understand English well enough to give informed consent. Participants will have regular check-ins during the study to monitor their health and see how well dapagliflozin is working. This trial is important because it aims to find new ways to protect the heart health of women during a critical time after pregnancy.

Gender

FEMALE

Eligibility criteria

• 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)