A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study will be conducted in a 1:1 fashion between the DAPA Group and the Control Group.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, the clinical team, and researchers will be blinded to group assignment.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
  • 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.
Experimental
Dapagliflozin 		10 Milligram (mg) orally
  • 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.
    Other names:
    • Farxiga

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Levi Anderson
734-763-0295
levijand@umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Levi Anderson
734-763-0295
levijand@umich.edu