Investigating exosome cargo in patients with preeclampsia

Exosome Cargo From Preeclamptic Patients Mediates Endothelial Dysfunction, Subsequent Cardiovascular Remodeling, and the Preeclamptic Phenotype

This study is testing how tiny particles from the placenta found in the blood of pregnant women might be linked to preeclampsia and heart changes to better understand this condition.

Quick facts

• Study type: Observational
• Enrollment: 64 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Alabama at Birmingham (other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT04154332 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the role of exosomes released from the placenta in the development of preeclampsia by isolating them from maternal blood and placental tissue. Researchers will analyze the biochemical, cellular, and molecular mechanisms of these exosomes in an animal model to understand their impact on preeclampsia and cardiovascular changes. The study will also investigate specific biomarkers, such as vasorin and angiotensin, to further elucidate their relationship in preeclamptic patients compared to healthy controls. Patient samples will be collected from volunteers delivering at the Women and Infants Center for detailed laboratory analysis.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 and older diagnosed with preeclampsia with severe features.

Not a fit: Patients without a diagnosis of preeclampsia or any pregnancy-induced hypertension disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and potential new biomarkers for diagnosing and managing preeclampsia.

How similar studies have performed: While the investigation of exosomal cargo in preeclampsia is a relatively novel approach, previous studies have indicated potential success in identifying biomarkers related to the condition.

Eligibility criteria

Inclusion

1. Preeclampsia patients: Age ≥ 18 years; Diagnosis of preeclampsia with severe features:

   1. BP ≥160/110 after 20 weeks gestation AND ≥300 mg/day proteinuria or protein/creatinine ratio of 0.3 mg/dL; OR
   2. BP ≥160/110 after 20 weeks gestation with any of the following co-conditions: platelet count less than 100,000 X 109/L, AST/ALT enzymes elevated to twice the upper limit of normal, serum creatinine ≥1.1 mg/dL or a doubling of the creatinine from baseline, pulmonary edema, new-onset headache, and/or visual disturbances.
2. Control patients: Age ≥ 18 years; no diagnosis of preeclampsia or any pregnancy-induced hypertension disorder.
3. Pre-clampsia patients will be defined as =140 mmHg systolic or =90mmHg diastolic BP with at least at least 2 occasions 4 hours apart after 20 weeks of gestation in previously normotensive women with at least one of the following symptoms: =300 mg/day proteinuria, protein/creatinine ratio of 0.3 mg/dL, platelet count \< 100,000 X 109/L, elevated liver enzymes, serum creatinine =1.1 mg/dL, pulmonary edema, or new-onset headache or visual disturbances.

   1. \>22w 0d gestational age -33w 6d GA (n=16)
   2. \>= 34 wGA (n=16)
4. Pre-eclampsia with severe features will be defined as blood pressure =160 mmHg systolic or =110 mmHg diastolic BP at least 2 occasions 4 hours apart after 20 weeks of gestation with any of the additional diagnostic criteria listed above.

   1. \>22w 0d gestational age -33w 6d GA (n=16)
   2. \>= 34 wGA (n=16)
5. Healthy gestational age matched controls:

   1. \>22w 0d gestational age -33w 6d GA (n=32)
   2. \>= 34 wGA (n=32)

Exclusion criteria:

1. Preeclampsia patients: Age \< 18 years; Any other diagnosis of pregnancy-induced hypertension that isn't preeclampsia with severe features (i.e. gestational hypertension or preeclampsia without severe features).
2. Control Patients: Age \< 18 years; Any diagnosis of pregnancy-induced hypertension.

Where this trial is running

Birmingham, Alabama

• University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)

Study contacts

• Principal investigator: Teshi Kaushik, MD — University of Alabama at Birmingham
• Study coordinator: Shanna H Graves

Conditions: Preeclampsia