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NCT06785116 · ClinicalTrials.gov registry record · Phase 4
A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
A Phase 4 study of Preeclampsia and Gestational Hypertension, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06785116: Recruiting Phase 4 study of Preeclampsia and Gestational Hypertension, sponsored by University of Michigan.
NCT06785116 is a Phase 4 study of Preeclampsia and Gestational Hypertension that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 200 participants, below the 1,122-participant average among 48 other Preeclampsia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06785116, a Phase 4 study of Preeclampsia and Gestational Hypertension, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The score will be summed and compared between groups.The components with outcome-based binary assessments by the following: * Biometric: change in systolic blood pressure (scores of 0 or 1) and change in body weight (scores of 0 or 1) * Echocardiogram: change in left ventricle wall thickness (scores of 0 or 1) and change in left ventricle mass (scores of 0 or 1) * Clinical: Non-hospitalization (scores of 0 or 1) and return to baseline antihypertensive needs (scores of 0 or 1) The total scores r
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dapagliflozin 10mg Tab
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-03-02 |
| Est. Completion | 2028-08 |
| Phase | Phase 4 |
What NCT06785116 shows while recruiting
NCT06785116 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,122-participant average among 48 other Preeclampsia trials with a reported enrollment target (82% lower).
The record links to 5 conditions, with Preeclampsia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06785116 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06785116 about?
NCT06785116 is a clinical study titled "A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)". 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 cardiovascu...
What is the current status of trial NCT06785116?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2025-03-02. Estimated completion is 2028-08.
What conditions does trial NCT06785116 study?
This clinical trial studies the following conditions: Preeclampsia, Gestational Hypertension, Hypertension in Pregnancy, Cardiovascular Complication, Superimposed Pre-Eclampsia.
What interventions are being tested in trial NCT06785116?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin 10mg Tab (DRUG).
Who is sponsoring clinical trial NCT06785116?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06785116 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Preeclampsia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06785116's enrollment target sits among peer trials
200 21st of 48 higher than 28 of 48 other Preeclampsia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preeclampsia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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