Dapagliflozin for Cardiovascular Risk After Hypertensive Pregnancies

(DAPA-HP Trial)

Overseen By Levi Anderson

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Michigan

Must be taking: Antihypertensives

Disqualifiers: Non-English, Pregnancy, Breastfeeding, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dapagliflozin, a medication, can reduce heart problems after a pregnancy with high blood pressure. Participants will receive either dapagliflozin or a placebo (a pill with no active medication) for six months to determine which group experiences better heart health outcomes. The trial seeks individuals who have had a pregnancy complicated by high blood pressure and are at risk of heart issues in the next five years. Eligible participants should have delivered their baby at the University of Michigan and have a history of high blood pressure during pregnancy. As a Phase 4 trial, this study involves an FDA-approved medication and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves participants already taking antihypertensive medications, it seems likely you can continue them. Please confirm with the trial coordinators.

What is the safety track record for dapagliflozin?

Research has shown that dapagliflozin is generally well-tolerated. In a study involving nearly 600 people with type 2 diabetes, dapagliflozin proved effective and safe. The study found no major differences in death rates between those taking dapagliflozin and those taking a placebo (a pill with no active medicine). Additionally, the FDA has approved dapagliflozin to lower the risk of death from heart problems and to reduce hospital visits for heart failure, indicating its safety for heart-related issues. While any medication can have side effects, evidence suggests dapagliflozin is safe for individuals similar to those in the study. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dapagliflozin is unique because it targets cardiovascular risk after hypertensive pregnancies by inhibiting the sodium-glucose co-transporter 2 (SGLT2), which is different from how traditional treatments for hypertension and heart conditions work. Most current treatments focus on lowering blood pressure or cholesterol without specifically addressing the cardiovascular complications that can arise after hypertensive pregnancies. Researchers are excited about dapagliflozin because it offers a novel approach, potentially reducing such risks by improving heart and kidney health, and it may offer added benefits in managing blood glucose levels, which is not a focus of existing treatments.

What evidence suggests that dapagliflozin might be an effective treatment for cardiovascular risk after hypertensive pregnancies?

Research has shown that dapagliflozin, a medication that blocks a protein called SGLT2, can help reduce heart risks. In this trial, participants will receive either dapagliflozin or a placebo to assess its effectiveness in improving heart health, particularly in those who had high blood pressure during pregnancy. Previous studies found that dapagliflozin improved heart outcomes in people with heart failure. This medication is already known to help with certain heart conditions, and experts agree it can reduce heart risks, making it a promising option for those concerned about heart health after pregnancy complications like high blood pressure. ^{1 6 7 8 9}

Who Is on the Research Team?

Ashley Hesson, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who have had hypertension or pre-eclampsia during pregnancy and are at high risk of cardiovascular issues within five years post-delivery. Participants will be randomly assigned to receive either the study drug or a placebo.

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

I am at least 23 weeks pregnant, confirmed by a medical method.

Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document

Exclusion Criteria

Intention to breastfeed after enrollment

I plan to try for a baby within 8 months after giving birth.

BNP ≥1000 pg/ml within 12 hours of delivery, clinical team to be notified of result

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dapagliflozin (10mg daily) or a placebo for cardiovascular risk reduction in the postpartum period

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin

Trial Overview The trial tests if dapagliflozin, taken daily at 10mg, can reduce cardiovascular risks in the postpartum period compared to a placebo. It's designed to check how well this works and if people are willing to stick with it.

How Is the Trial Designed?

Group I: Dapagliflozin Experimental Treatment 1 Intervention

10 Milligram (mg) orally

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Society for Maternal-Fetal Medicine Foundation

Collaborator

Trials

1

Recruited

100+

American Association of Obstetricians and Gynecologists Foundation

Collaborator

Trials

1

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06785116

A Randomized, Placebo-controlled Trial of DAPAgliflozin ... The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group. Official Title. A Randomized, Placebo-controlled Trial of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937825001814

Peripartum dapagliflozin improves late-life maternal ... SGLT2 (sodium-glucose cotransporter-2) inhibition improves outcomes in heart failure, a later-life risk that disproportionately affects those with preeclampsia ...

3. withpower.com withpower.com/trial/phase-4-hypertension-1-2025-c4e17

Dapagliflozin for Cardiovascular Risk After Hypertensive ... This trial is for individuals who have had hypertension or pre-eclampsia during pregnancy and are at high risk of cardiovascular issues within five years post- ...

4. sigma.larvol.com sigma.larvol.com/ott.php?e1=503&e2=19217&sourcepg=TZ

Online Trial Tracker NCT06785116: A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive ...

5. ctv.veeva.com ctv.veeva.com/study/a-randomized-placebo-controlled-trial-of-dapagliflozin-dapa-for-cardiovascular-risk-reduction-in

A Randomized, Placebo-controlled Trial of DAPAgliflozin ... The study hypothesizes: The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group. Diagnosed with a ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf

FARXIGA (dapagliflozin) - accessdata.fda.gov ... FARXIGA reduces the risk of cardiovascular death and hospitalization for heart failure. Of 4744 patients, 2373 were randomized to. FARXIGA 10 mg and 2371 to ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1812389

Dapagliflozin and Cardiovascular Outcomes in Type 2 ... The rate of death from any cause did not differ significantly between the groups (6.2% in the dapagliflozin group and 6.6% in the placebo group; ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8855933/

Effectiveness and safety of dapagliflozin in real-life patients In this study, the effectiveness and safety of dapagliflozin were analysed in nearly 600 patients with T2D, showing a high capacity of dapagliflozin to reduce ...

9. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2022/new-data-show-farxiga-significantly-lowers-the-risk-of-cardiovascular-death-in-patients-with-heart-failure.html

New data show FARXIGA significantly lowers the risk of ... Pre-specified pooled analysis from Phase III trials demonstrated reduction in CV death by 14% and reduction in death from any cause by 10% ...