GDMT for Preeclampsia

(GDMT For PE Trial)

Overseen By Colleen Duncan, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Cardiomyopathy, Heart disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 months

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-center, open-label pilot study looking at how Guideline-directed management and therapy (GDMP) in post-partum women with preeclampsia can improve Global Longitudinal Strain (GLS).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Guideline-directed Management and Therapy (GDMT) for preeclampsia?

The research suggests that careful monitoring and management of preeclampsia, including remote patient monitoring and telehealth, can improve outcomes by ensuring timely intervention and reducing complications. While specific data on GDMT for preeclampsia is limited, similar approaches in managing hypertension during pregnancy have shown to lower risks when pregnancies are closely monitored. ^{1 2 3 4 5}

Is GDMT for Preeclampsia safe for humans?

The safety of GDMT (Guideline-directed Management and Therapy) for preeclampsia isn't directly addressed in the research, but treatments like low-dose aspirin and certain blood pressure medications (like methyldopa and labetalol) are generally considered safe during pregnancy. However, new treatments are being explored, and their safety for the developing fetus is still being studied. ^{2 3 6 7 8}

How is GDMT treatment for preeclampsia different from other treatments?

GDMT for preeclampsia is unique because it follows a structured approach based on established guidelines for managing heart failure, which may include specific medications and therapies tailored to improve heart function. This approach is different from the standard treatments for preeclampsia, which typically focus on managing high blood pressure and preventing seizures with medications like magnesium sulfate and hydralazine. ^{2 9 10 11 12}

Research Team

Sajid H Shahul, MD PHD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for African American women aged 18-45 who were part of the PARENT study, delivered a single baby at UCMC, have high blood pressure postpartum, and were diagnosed with preeclampsia. It's not for those unable to consent or operate the monitoring device, or with preexisting heart disease, lung disease, diabetes, kidney disease, or multiple births.

Inclusion Criteria

Diagnosed with preeclampsia

Blood pressure >120/80 at the time of their 6-month visit in the PARENT study

Completed the 6 month visit in the PARENT study

Exclusion Criteria

I cannot use the RPM tablet device by myself.

I have heart disease related to blocked arteries or heart valve issues.

Patients with multiple gestations

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into either the GDMP treatment arm with remote patient monitoring or the standard of care observational arm

3 months

Monthly telephone interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up clinic visit with TTE and other assessments

3 months

1 visit (in-person)

Extension

Participants may opt into an additional 3-month extension of the study

3 months

Treatment Details

Interventions

• Guideline-directed Management and Therapy
• Remote Patient Monitoring

Trial Overview The study tests if Guideline-directed Management and Therapy (GDMT) can improve heart function in postpartum African American women with preeclampsia by using Remote Patient Monitoring to track their health.

Participant Groups

Group I: Observational Arm Active Control 1 Intervention

35 Subjects will be placed in the sub-study Obervational arm. These subjects will not reveive the remote patient monitoring program and will continue with thier standard of care treatment for the duration of the study.

Group II: Treatment Arm Active Control 1 Intervention

35 Subjects will be placed in the sub-study treatment arm. These subjects will receive the remote patient monitoring program therapy offered by the University of Chicago heart failure program.

Guideline-directed Management and Therapy is already approved in European Union, United States for the following indications:

Approved in European Union as Standard Heart Failure Therapy for:

• Heart Failure with Reduced Ejection Fraction
• Postpartum Cardiomyopathy

Approved in United States as Guideline-directed Management and Therapy for:

• Heart Failure with Reduced Ejection Fraction
• Postpartum Cardiomyopathy
• Preeclampsia-related Cardiac Dysfunction

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Expectant management of pre-eclampsia can lead to good outcomes for most patients with mild disease, especially when they are far from term, emphasizing the importance of individualized care based on maternal and fetal conditions.

Severe pre-eclampsia, particularly before 34 weeks' gestation or in cases of HELLP syndrome, significantly increases the risk of maternal and perinatal complications, necessitating management in specialized hospitals equipped for intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pre-eclampsia remote from term. Sibai, BM.[2005]

Hypertensive disorders affect about 10% of pregnancies, with careful monitoring significantly reducing neonatal mortality, highlighting the importance of identifying women at risk for preeclampsia for better management.

Prophylactic low-dose aspirin may help prevent preeclampsia, but its effectiveness in reducing severe cases and improving outcomes is still uncertain; current treatments for hypertension in pregnancy include hydralazine, labetalol, and methyldopa, while magnesium sulfate is crucial for managing preeclampsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hypertension and its treatment in pregnancy]. Jerie, P.[2006]

Pre-eclampsia is a serious pregnancy condition characterized by high blood pressure and potential organ damage, which can occur even without proteinuria, and it requires careful monitoring and management based on the severity and gestational age of the pregnancy.

The review emphasizes the importance of both nonpharmacological and pharmacological treatments for managing pre-eclampsia, particularly during hypertensive crises, and highlights the need for tailored obstetric care depending on the stage of pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-eclampsia/Eclampsia. Peraçoli, JC., Borges, VTM., Ramos, JGL., et al.[2020]

The guidelines aim to improve the diagnosis, management, and prevention of hypertensive disorders of pregnancy (HDPs), particularly preeclampsia, which can lead to serious complications for both mothers and babies.

By implementing these evidence-based recommendations, healthcare providers may significantly reduce the incidence of HDPs and improve maternal and fetal outcomes, as supported by a comprehensive review of literature up to December 2020.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guideline No. 426: Hypertensive Disorders of Pregnancy: Diagnosis, Prediction, Prevention, and Management. Magee, LA., Smith, GN., Bloch, C., et al.[2022]

Preeclampsia is a serious pregnancy condition that often shows no symptoms, making regular screening in the second half of pregnancy essential for early detection and management, with the primary goal being the safety of the mother.

Delivery of the infant and placenta is the only definitive treatment for preeclampsia, and while expectant management may be safe for select women before 34 weeks' gestation, close monitoring of both maternal and fetal conditions is crucial to prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of preeclampsia. Dekker, GA.[2022]

Recent large randomized trials indicate that low-dose aspirin does not significantly reduce the incidence of preeclampsia or improve perinatal outcomes, particularly in women with preexisting conditions like hypertension or diabetes.

Epidural anesthesia is considered safe for pregnant women taking low-dose aspirin, even those with severe preeclampsia, suggesting that pain management options remain viable for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What we have learned about preeclampsia. Sibai, BM., Caritis, S., Hauth, J.[2019]

Preeclampsia affects 2-8% of pregnancies and is linked to serious health risks, highlighting the need for effective treatments; current research is exploring repurposed drugs like proton pump inhibitors and sildenafil citrate, which have shown promise in preclinical studies.

Innovative targeted delivery systems, such as nanoparticle technology, are being developed to safely administer these therapeutics directly to the placenta, potentially improving treatment outcomes while minimizing risks to the fetus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel approaches to combat preeclampsia: from new drugs to innovative delivery. de Alwis, N., Binder, NK., Beard, S., et al.[2021]

Hypertensive disorders during pregnancy can lead to serious health risks for mothers and babies, making it crucial to identify and manage high blood pressure effectively, especially when readings reach ≥ 150/95 mmHg or higher.

Current guidelines recommend using specific antihypertensive medications like methyldopa, labetalol, and calcium antagonists for treatment, particularly in women with a history of hypertension, as they are at increased risk for cardiovascular issues later in life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension in Pregnancy: A Diagnostic and Therapeutic Overview. Cífková, R.[2023]

Preeclampsia, affecting 0.5 to 7% of pregnancies, poses significant risks to both mothers and babies, necessitating treatment that often involves ending the pregnancy and using antihypertensive drugs to manage complications.

Low-dose aspirin is an effective preventive treatment for preeclampsia, reducing the risk of recurrence by 10-15%, prematurity by 8%, and perinatal mortality by 14%, although it does not significantly impact intra-uterine growth restriction or perinatal death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Latest developments: management and treatment of preeclampsia]. Winer, N., Tsasaris, V.[2022]

Preeclampsia is diagnosed by significant increases in blood pressure after the 20th week of pregnancy, and severe cases can lead to eclampsia, which involves seizures in about 0.2% of affected patients.

Magnesium sulfate is the primary treatment for preventing and controlling seizures in preeclamptic patients, while intravenous hydralazine is preferred for managing severe hypertension; low-dose aspirin may help prevent preeclampsia in at-risk women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of preeclampsia and eclampsia. McCombs, J.[2013]

A survey of 87 obstetricians revealed that while most recognize the importance of aspirin in reducing preeclampsia risk, a significant number do not administer magnesium sulfate during labor to prevent seizures in patients without severe features, indicating a gap in adherence to recommended practices.

Maternal-fetal medicine (MFM) specialists were more likely to follow guidelines, such as prescribing aspirin for prevention and counseling patients with abnormal biomarkers, highlighting the need for improved education among general obstetricians to align practices with current recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetricians' knowledge and practices regarding the management of preeclampsia. Snead, CM., Strassberg, E., Overcash, R., et al.[2021]

Recent studies have shown promising results in screening for preeclampsia before symptoms appear, which could improve early detection and management of hypertension during pregnancy.

While first-line medications for treating hypertensive complications of preeclampsia remain largely unchanged due to their established safety and efficacy, new second-line drugs have demonstrated effectiveness and safety, but further long-term studies are needed to determine if they can replace current standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathophysiology and medical management of systemic hypertension in preeclampsia. Frishman, WH., Veresh, M., Schlocker, SJ., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Management of pre-eclampsia remote from term. [2005]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

[Hypertension and its treatment in pregnancy]. [2006]

3. Brazil pubmed.ncbi.nlm.nih.gov

Pre-eclampsia/Eclampsia. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Guideline No. 426: Hypertensive Disorders of Pregnancy: Diagnosis, Prediction, Prevention, and Management. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Management of preeclampsia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

What we have learned about preeclampsia. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Novel approaches to combat preeclampsia: from new drugs to innovative delivery. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Hypertension in Pregnancy: A Diagnostic and Therapeutic Overview. [2023]

9. France pubmed.ncbi.nlm.nih.gov

[Latest developments: management and treatment of preeclampsia]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Treatment of preeclampsia and eclampsia. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Obstetricians' knowledge and practices regarding the management of preeclampsia. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Pathophysiology and medical management of systemic hypertension in preeclampsia. [2019]