Clinical trial NCT05534932: Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women
Official title: Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preeclampsia Postpartum
Keywords: Preeclampsia
Postpartum GLS Levels
Postpartum Activin A Levels
Cardiac Postpartum Therapy
Hypertension
Cardiovascular disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Subjects will be randomized at baseline into one of two arms for the purposes of the sub-study. One arm will receive the GDMP, which includes the RPM program. The other arm will not receive the GDMP and will continue thier usual standard of care course per thier treating physician.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: This study is looking at when given GDMP in post-partum women with preeclampsia, compared to the current standard of care, can this therapy improve Global Longitudinal Strain (GLS) at 9 months. Subjects who agree to participate and who have already completed the PARENT study (NCT04479072) at 6-months will be randomized in this study to either the GDMP (Treatment) arm or the standard of care (Observational) arm. Subjects that agree to participate in the extension part of the study, will add on an additional 3 months.

The primary objective of this study is to mechanistically determine the effect of GDMT administered at six months postpartum on GLS at nine months postpartum in African- American patients at high risk due to elevated blood pressures (\>120/80 mmHg).

The trial biostatistician will create the randomization schedules using computer-generated random numbers and will have access to treatment group allocation. Below are further details on each arm.

Treatment Arm: Subjects randomized into the treatment arm will be enrolled into the remote patient monitoring program (RPM). Subjects who enroll in the sub-study will utilize the RPM by the University of Chicago Heart Failure Program. This program enables providers to track the number of critical vitals in real time. Patients are equipped and trained to monitor blood pressure, heart rate, weight, temperature, and medication adherence, through a Bluetooth-enabled tablet that integrates and transmits data to the clinic providers and advanced practitioners. This system is currently in use by the heart failure program at the University of Chicago, including hospital-to-home transition care after hospitalization for decompensated heart failure and long-term outpatient management of chronic heart failure, hypertension, atrial fibrillation, and ischemic heart disease. The heart failure team will provide the tablet, blood pressure cuff, weight scale and training at the subjects baseline visit.

Observational Arm: Subjects randomized to this arm will receive the standard of care based upon the American Heart Association (AHA) and American Congress of Obstetricians and Gynecologists (ACOG) guidelines, which include counseling of increased cardiovascular risk, lifestyle modifications, including a healthy diet, exercise, smoking cessation, and risk factor intervention as determined by the primary care physician. They will not be receiving the RPM program equipment.

Follow-up clinic visit approximately 3 months after they have been randomized will be scheduled in both arms. At this visit the study team will;

Perform a Transthoracic echocardiogram (TTE) Obtain Vital signs Physical Exam Adverse Event check Concomitant Medication check Blood draw for laboratory test

In addition, the study team will conduct monthly telephone interviews of all randomized trial participant's for concomitant medications, adverse events/side effects, and study drug compliance.

Eligibility criteria: Inclusion Criteria:

1. Adults between 18 and 45 years of age
2. African American
3. \>120/80 BP at the time of their 6-month visit in the PARENT study
4. Diagnosed with preeclampsia
5. Initially presented to University of Chicago Medical Center (UCMC) for a Singleton Gestation Delivery
6. Completed the 6 month visit in the PARENT study

Exclusion Criteria:

1. Those who cannot provide consent
2. patients with preexisting cardiomyopathy, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestations,
3. Unable to operate the RPM tablet device

Primary outcomes:
measure: GLS percentages
timeFrame: 3 Months
Secondary outcomes:
measure: Difference in Activin A levels
timeFrame: 3 Months
measure: Left Atrial Volume Index
timeFrame: 3 Months
measure: Deceleration Time
timeFrame: 3 Months
measure: Mean Arterial Pressure
timeFrame: 3 Months
measure: Ejection Fraction
timeFrame: 3 Months
measure: Mitral Annular Motion
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
Study officials:
affiliation: University of Chicago
name: Sajid H Shahul, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: