A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
A Randomized, Placebo-controlled Trial of DAPAgliflozin for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether dapagliflozin can lower heart and blood vessel risks after a pregnancy with high blood pressure. It is for patients at high risk of these health problems within five years after delivery. Participants are assigned by chance to take dapagliflozin (10 mg) or a placebo (a pill with no study drug) daily for six months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be admitted for delivery at the University of Michigan, or join its blood pressure tracking program after delivering there.
- Deliver at 23 weeks of pregnancy or later. Single or multiple births are allowed, with or without birth defects.
- Be able to read, speak, and understand English, and agree to sign the English consent form.
- Have high blood pressure during pregnancy documented in your medical record, or be taking medicine for long-term high blood pressure when admitted.
- Report your planned birth control method during the consent process.
- Have at least two blood pressure readings of 160/110 mmHg or higher, at least 60 minutes apart. If you do not meet this rule but meet the others, you may qualify with a BNP blood test within 12 hours of delivery showing at least 100 pg/ml. BNP helps measure heart risk.
Who can't join
- Do not speak English.
- Are still pregnant.
- Want to become pregnant within eight months after delivery.
- Plan to breastfeed after joining the study.
- Have a BNP blood test result of 1,000 pg/ml or higher within 12 hours of delivery. The care team will be told.
- Have other health conditions that may affect how heart and blood vessel risk is measured, under the study rules.
- Have a medical reason that makes dapagliflozin unsafe for you, under the study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (1)
MI
- University of Michigan · Ann Arbor, MI 48109Levi Anderson · Study contact · 734-763-0295 · levijand@umich.eduAshley Hesson, MD, PhD · Principal investigatorMore trials in Ann Arbor