Aspirin and Preeclampsia
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|ClinicalTrials.gov Identifier: NCT04479072|
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : March 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Preeclampsia Postpartum||Drug: Aspirin 81 mg Drug: Placebo||Phase 4|
The primary objective of this trial is to mechanistically compare the effect of postpartum aspirin therapy versus placebo in preeclamptic patients identified as high risk for postpartum cardiac dysfunction using Activin A. The intent is to evaluate the effect of selective treatment based on Activin A status rather than treatment for all postpartum preeclamptic women.
After informed consent, 5cc of blood will be collected from the median cubital vein on antepartum admission to labor and delivery for Activin A screening. The patient will be subjected to a total of 2 such blood draws- a single draw at screening, one at their 6 month postpartum visit. The member of the study team carrying out the blood draw will immediately label the specimen in the presence of the subject, after the collection and before leaving the patient's bedside, room, cubicle or surgical suite. The guidelines from, "The University of Chicago Medicine Policy and Procedure Manual - Phlebotomy Service Infection Control 04-26" will be followed for specimen collection and transport. Activin A levels based on our previous data will be classified as elevated if greater than 23.74 ng/ml in the last trimester of pregnancy (4). This threshold was selected on the basis of our prior data suggesting an inflection point in the rate of abnormal GLS postpartum at this concentration. Patients with elevated Activin A levels will be randomized to a placebo group receiving routine postpartum cardiovascular standard of care or to an intervention arm with 81 mg daily aspirin therapy added to care at their postpartum delivery stay. The rationale for only randomizing women with elevated Activin A levels is that among women with an elevated Activin A antepartum, 85% developed abnormalities in GLS at one year postpartum versus 25% in women with non-elevated Activin A levels. Women whose Activin A levels are not elevated will receive the same care as that provided to the placebo group and will also be followed for one year (n=60). All other subjects who meet the criterial of elevated Activin A levels, will either be randomized to the aspirin therapy group (N = 60) or a placebo group (N = 60). The investigators choose postpartum Aspirin therapy post-delivery to avoid any immediate delivery or C-section associated bleeding complications and to coincide with their postpartum well-baby visit.
The investigator will determine the blood Activin A levels at 6 months after delivery, measured using ELISA. The samples will be assayed for Activin A level using commercially available ELISA kits (Ansh Labs; Webster, TX) following the manufacturer's recommendations. Each sample will be run in triplicate and the values averaged. GLS at 6 months after delivery will be measured using fully automated vendor-independent software that uses a computer learning algorithm to facilitate endocardial border detection.
Mean arterial pressure, and other indices of systolic and diastolic function (ejection fraction (EF), early filling/atrial contraction (E/A), deceleration time (DT), mitral annular motion (E'), and left atrial volume index) measured at the baseline and 6 months postpartum. Transthoracic echocardiograms will be performed and reported according to American Society of Echocardiography guidelines. Ejection fraction and left atrial volume will be calculated using the Simpson's biplane disc method. Left ventricular mass index (LVMI) will be calculated using the area length method.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||Subjects will be randomized to two arms. One arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit. The other arm will receive daily dose of placebo pill at their baseline visit. There will be a third arm, where subjects will not receive any study drug and will be considered the observational arm.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||The study team and all randomized subjects will be blinded to which arm they were placed in. Subjects in the observational group will not be randomized and not given an intervention.|
|Official Title:||Aspirin to Prevent Cardiac Dysfunction in Preeclampsia|
|Actual Study Start Date :||February 15, 2021|
|Estimated Primary Completion Date :||January 1, 2026|
|Estimated Study Completion Date :||February 28, 2026|
Active Comparator: Intervention Arm
60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of aspirin 81 mg.
Drug: Aspirin 81 mg
Subjects in the interventional arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
Other Name: acetylsalicylic acid 81 mg
Placebo Comparator: Placebo Arm
60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of a placebo pill
Subjects in this group will receive a daily dose of a placebo pill, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
No Intervention: Observational Arm
60 subjects will be placed in the observational arm. These subjects will not receive any intervention but will be followed and asked to return at the same time interval as the other 2 groups.
- Difference in Activin A levels [ Time Frame: 6 Months ]The primary outcome will compare Activin A levels at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.
- GLS percentages [ Time Frame: 6 months ]The primary outcome will compare GLS levels as a percentage (%) at 6 months between patients randomized to aspirin therapy versus placebo and the observational group.
- Mean Arterial Pressure [ Time Frame: 6 Months ]Difference in mean arterial pressure in subjects, from their baseline to 6 month TTE
- Ejection Fraction % [ Time Frame: 6 Months ]Comparing the difference in the ejection fraction percentages, from the subjects baseline to 6 month TEE.
- Deceleration Time, [ Time Frame: 6 Months ]Comparing the difference between deceleration time from subjects from their baseline to 6 month TTE.
- Mitral Annular Motion [ Time Frame: 6 Months ]Comparing the difference between mitral annular motion, in millimeters (mm), from subjects baseline to 6 month TTE.
- Left Atrial Volume Index [ Time Frame: 6 Months ]Comparing the difference between left atrial volume index, from the subjects baseline to 6 month TTE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479072
|Contact: Sajid Shahul, MD, PhDemail@example.com|
|Contact: Edward H Foxfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago Hospital||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Sajid Shahul, MD, PhD 773-398-2956 email@example.com|
|Contact: John Dreixler, PhD 773-702-6700 JDreixle@dacc.uchicago.edu|
|Sub-Investigator: Sarosh Rana, MD|