University of Michigan
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.
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 *…
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.
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.
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