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| Name | Class |
|---|---|
| Society for Maternal-Fetal Medicine Foundation | UNKNOWN |
| American Association of Obstetricians and Gynecologists Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Dapagliflozin | Experimental | 10 Milligram (mg) orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular risk reduction score | The score will be summed and compared between groups.The components with outcome-based binary assessments by the following:
| Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients screened | 2-year recruitment period | |
| The number of patients screen-outs vs screen-ins | These will be the participants that qualify either by blood pressure or laboratory parameter (BNP) (screen-ins) or if not eligible (screen-outs). |
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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
Determined to be at least 23 and 0/7 weeks of gestation based on a clinically acceptable dating method (can be a single or multifetal gestation with or without the presence of fetal anomalies) at the time of delivery
Consents to participation and must understand/read/speak English with the ability to understand and willingness to sign a written informed consent in English
Diagnosed with a hypertensive pregnancy by either of the following criteria:
Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document.
Has two or more blood pressures ≥160/110 Millimeters of mercury (mmHg) at least 60 minutes apart
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Levi Anderson | Contact | 734-763-0295 | levijand@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashley Hesson, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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The study will be conducted in a 1:1 fashion between the DAPA Group and the Control Group.
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Participants, the clinical team, and researchers will be blinded to group assignment.
|
| Dapagliflozin 10mg Tab | Drug | 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. |
|
|
| 2-year recruitment period |
| Reasons for ineligibility and refusal to participate | 2-year recruitment period |
| Patient-stated adherence | This will be collected by the patient medication diary and study visit questionnaire. | baseline to 6 months |
| Patient reported barriers to adherence | Participants will answer 2 questions regarding missed doses of medications. These will be summarized. | baseline to 6 months |
| Loss to follow-up rates | Information on loss to follow-up (where available) will be reported to inform future work. | Baseline to 6 months |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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