RECRUITING

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

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Conditions

Gestational HypertensionHypertension in PregnancyPre-EclampsiaSuperimposed Pre-EclampsiaCardiovascular ComplicationMedicationPlaceboPostpartum periodCardiovascular risk reductionEchocardiogram

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-02
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06785116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * Consents to participation and must understand/read/speak English with the ability to understand and willingness to sign a written informed consent in English
  4. * Diagnosed with a hypertensive pregnancy by either of the following criteria:
  5. * Taking an antihypertensive medication for the diagnosis of chronic or essential hypertension at the time of admission
  6. * Hypertension, chronic hypertension, or essential hypertension must be present in the prospective participant's medical record
  7. * Antihypertensive" can be any medication taken for the purpose of blood pressure control per the medical record
  8. * A documented hypertensive disorder of pregnancy (gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, or eclampsia) prior to delivery
  9. * Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document.
  10. * Has two or more blood pressures ≥160/110 Millimeters of mercury (mmHg) at least 60 minutes apart
  11. * 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)
  1. * Non-English speaking
  2. * Ongoing pregnancy
  3. * Stated desire to become pregnant within 8 months post-delivery
  4. * Intention to breastfeed after enrollment
  5. * BNP ≥1000 pg/ml within 12 hours of delivery, clinical team to be notified of result
  6. * Comorbidities that may affect cardiovascular risk assessment (per protocol)
  7. * Contraindication to dapagliflozin (per protocol)

Contacts and Locations

Study Contact

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

Principal Investigator

Ashley Hesson, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Ashley Hesson, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-02
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-03-02
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Medication
  • Placebo
  • Postpartum period
  • Cardiovascular risk reduction
  • Echocardiogram

Additional Relevant MeSH Terms

  • Gestational Hypertension
  • Hypertension in Pregnancy
  • Pre-Eclampsia
  • Superimposed Pre-Eclampsia
  • Cardiovascular Complication