Dapagliflozin for Cardiovascular Risk After Hypertensive Pregnancies

(DAPA-HP Trial)

Overseen By Levi Anderson

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Michigan

Must be taking: Antihypertensives

Disqualifiers: Non-English, Pregnancy, Breastfeeding, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

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.

Research Team

Ashley Hesson, MD, PhD

Principal Investigator

University of Michigan

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

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.

Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document

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

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

Treatment Details

Interventions

• Dapagliflozin

Trial Overview 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.

Participant Groups

Group I: Dapagliflozin Experimental Treatment 1 Intervention

10 Milligram (mg) orally

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Society for Maternal-Fetal Medicine Foundation

Collaborator

Trials

1

Recruited

100+

American Association of Obstetricians and Gynecologists Foundation

Collaborator

Trials

1

Recruited

100+