Actively Recruiting
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
Led by University of Michigan · Updated on 2026-03-04
200
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
S
Society for Maternal-Fetal Medicine Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted for delivery at the University of Michigan Labor and Delivery unit or enrolled in the UM postpartum blood pressure monitoring program after delivery at the UM unit
- At least 23 weeks and 0 days pregnant based on clinical dating at delivery
- Able to read, speak, and understand English and willing to sign informed consent in English
- Diagnosed with hypertensive pregnancy by taking antihypertensive medication or documented hypertension or hypertensive pregnancy disorder in medical records
- Plans to use a contraceptive method during the study
- Has two or more blood pressure readings of 160/110 mmHg or higher at least 60 minutes apart, or if not, has a brain natriuretic peptide (BNP) level of 100 pg/ml or higher within 12 hours of delivery
You will not qualify if you...
- Non-English speaking
- Currently pregnant
- Intends to become pregnant within 8 months after delivery
- Plans to breastfeed after enrolling in the study
- Brain natriuretic peptide (BNP) level of 1000 pg/ml or higher within 12 hours of delivery
- Has other health conditions that affect cardiovascular risk assessment as noted in the protocol
- Has contraindications to dapagliflozin as described in the protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
L
Levi Anderson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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