Trials / Recruiting
RecruitingNCT06785116
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
- Gestational Hypertension
- Hypertension in Pregnancy
- Pre-Eclampsia
- Superimposed Pre-Eclampsia
- Cardiovascular Complication
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | 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. |
| DRUG | Dapagliflozin 10mg Tab | 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. |
Timeline
- Start date
- 2025-03-02
- Primary completion
- 2028-08-01
- Completion
- 2028-08-01
- First posted
- 2025-01-21
- Last updated
- 2026-03-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06785116. Inclusion in this directory is not an endorsement.