Dapagliflozin for Cardiovascular Risk After Hypertensive Pregnancies
(DAPA-HP Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAshley Hesson, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Michigan

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals who have had hypertension or pre-eclampsia during pregnancy and are at high risk of cardiovascular issues within five years post-delivery. Participants will be randomly assigned to receive either the study drug or a placebo.

Inclusion Criteria

Consents to participation and must understand/read/speak English with the ability to understand and willingness to sign a written informed consent in English

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

I am at least 23 weeks pregnant, confirmed by a medical method.

+3 more

Exclusion Criteria

Intention to breastfeed after enrollment

I plan to try for a baby within 8 months after giving birth.

BNP ≥1000 pg/ml within 12 hours of delivery, clinical team to be notified of result

+4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dapagliflozin (10mg daily) or a placebo for cardiovascular risk reduction in the postpartum period

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial tests if dapagliflozin, taken daily at 10mg, can reduce cardiovascular risks in the postpartum period compared to a placebo. It's designed to check how well this works and if people are willing to stick with it.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DapagliflozinExperimental Treatment1 Intervention

10 Milligram (mg) orally

Group II: PlaceboPlacebo Group1 Intervention