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GDMT for Preeclampsia (GDMT For PE Trial)

N/A

Recruiting

Led By Sajid H Shahul, MD PHD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

GDMT For PE Trial Summary

This trial is testing if a specific type of post-partum care can improve heart function in women who had preeclampsia during pregnancy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves remote patient monitoring rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing the device and potential privacy concerns related to data sharing.

GDMT For PE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GLS percentages

Secondary outcome measures

Deceleration Time

Difference in Activin A levels

Ejection Fraction

+3 more

GDMT For PE Trial Design

2Treatment groups

Active Control

Group I: Observational ArmActive Control1 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 ArmActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,707 Total Patients Enrolled

Sajid H Shahul, MD PHDPrincipal InvestigatorUniversity of Chicago

Media Library

Guideline-directed Management and Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05534932 — N/A

Pre-eclampsia Research Study Groups: Observational Arm, Treatment Arm

Pre-eclampsia Clinical Trial 2023: Guideline-directed Management and Therapy Highlights & Side Effects. Trial Name: NCT05534932 — N/A

Guideline-directed Management and Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05534932 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the qualifications to be part of this medical research?

"To qualify for the study, potential participants must be between 18 and 45 years old and demonstrate a diagnosis of pre-eclampsia. The trial is only open to 70 enrollees."

Answered by AI

Is the age bracket for this medical experiment restricted to those younger than 30?

"For this particular research, only individuals between 18 and 45 years old are eligible. For those outside of that age bracket, there are 9 separate clinical trials for minors and 46 for seniors."

Answered by AI

Is this particular clinical research accepting new participants?

"Affirmative, clinicaltrials.gov displays that this research is actively searching for participants. It was first registered on October 27th 2022 and amended on November 16th 2022. Seventy subjects are needed from 1 site of the hospital network."

Answered by AI

How many participants have signed up for the research thus far?

"Affirmative. Clinicaltrials.gov data confirms that this research study, initially posted on October 27th 2022, is actively looking for candidates to join the trial. Approximately 70 subjects are needed from 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women

2022. "Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05534932.