Clinical trial NCT06785116: A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
Official title: A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gestational Hypertension
Hypertension in Pregnancy
Pre-Eclampsia
Superimposed Pre-Eclampsia
Cardiovascular Complication
Keywords: Medication
Placebo
Postpartum period
Cardiovascular risk reduction
Echocardiogram
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Society for Maternal-Fetal Medicine Foundation
name: American Association of Obstetricians and Gynecologists Foundation
First posted: 2025-01-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted in a 1:1 fashion between the DAPA Group and the Control Group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cardiovascular risk reduction score
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: The number of patients screened
timeFrame: 2-year recruitment period
measure: The number of patients screen-outs vs screen-ins
timeFrame: 2-year recruitment period
measure: Reasons for ineligibility and refusal to participate
timeFrame: 2-year recruitment period
measure: Patient-stated adherence
timeFrame: baseline to 6 months
measure: Patient reported barriers to adherence
timeFrame: baseline to 6 months
measure: Loss to follow-up rates
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ashley Hesson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: