Cardiovascular Complication, Gestational Hypertension, Hypertension in Pregnancy, Pre-Eclampsia, Superimposed Pre-Eclampsia
Conditions
Keywords
Medication, Placebo, Postpartum period, Cardiovascular risk reduction, Echocardiogram
Brief 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.
Interventions
DRUGPlacebo
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.
DRUGDapagliflozin 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.
Sponsors
University of Michigan
Society for Maternal-Fetal Medicine Foundation
American Association of Obstetricians and Gynecologists Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, the clinical team, and researchers will be blinded to group assignment.
Intervention model description
The study will be conducted in a 1:1 fashion between the DAPA Group and the Control Group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: * Taking an antihypertensive medication for the diagnosis of chronic or essential hypertension at the time of admission * Hypertension, chronic hypertension, or essential hypertension must be present in the prospective participant's medical record * Antihypertensive" can be any medication taken for the purpose of blood pressure control per the medical record * A documented hypertensive disorder of pregnancy (gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, or eclampsia) prior to delivery * 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 * If an admitted patient does not meet this blood pressure criterion but is otherwise eligible, participants can consent to have a BNP drawn within 12 hours of delivery as an alternative measure of cardiovascular risk (if the brain natriuretic peptide (BNP) is ≥100 Picograms per milliliter (pg/ml), participants are eligible to participate)
Exclusion criteria
* Non-English speaking * Ongoing pregnancy * Stated desire to become pregnant within 8 months post-delivery * Intention to breastfeed after enrollment * BNP ≥1000 pg/ml within 12 hours of delivery, clinical team to be notified of result * Comorbidities that may affect cardiovascular risk assessment (per protocol) * Contraindication to dapagliflozin (per protocol)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular risk reduction score | Baseline, 6 months | 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 range from 0-6 with a higher score indicating greater cardiovascular risk reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients screened | 2-year recruitment period | — |
| The number of patients screen-outs vs screen-ins | 2-year recruitment period | These will be the participants that qualify either by blood pressure or laboratory parameter (BNP) (screen-ins) or if not eligible (screen-outs). |
| Reasons for ineligibility and refusal to participate | 2-year recruitment period | — |
| Patient-stated adherence | baseline to 6 months | This will be collected by the patient medication diary and study visit questionnaire. |
| Patient reported barriers to adherence | baseline to 6 months | Participants will answer 2 questions regarding missed doses of medications. These will be summarized. |
| Loss to follow-up rates | Baseline to 6 months | Information on loss to follow-up (where available) will be reported to inform future work. |
Countries
United States
Contacts
CONTACTLevi Anderson
PRINCIPAL_INVESTIGATORAshley Hesson, MD, PhD
University of Michigan
Outcome results
None listed