Clinical trial · Observational
Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia
NCT04063397CI-TRIAL-00072881ECHOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Complication | — | UNRESOLVED | — |
| Preeclampsia Severe or Mild | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Diagnostic Test | — | UNRESOLVED |
| Echocardiogram | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Preeclampsia
- description
- 40 patients diagnosed with preeclampsia with or without severe features
- interventionNames
- Diagnostic Test: Echocardiogram
- Diagnostic Test: Blood draw
- label
- Control
- description
- 20 Control group of patients without hypertensive disorders of pregnancy
- interventionNames
- Diagnostic Test: Echocardiogram
- Diagnostic Test: Blood draw
Primary outcomes (1)
- measure
- Cardiac dysfunction
- timeFrame
- From delivery up to 3-6 months postpartum
- description
- The following parameters will be measured to assess cardiac dysfunction: 1. LV Size/function 1. Biplane Method of Disks LVEF (a4C and 2C views for EDV and ESV) 2. LV Fractional shortening- Septal thickness and PW thickness 3. LV Strain- Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain 4. 3D LV EF 5. Tei index 6. Analysis of LV diastolic function- Mitral E wave, Mitral A wave, Mitral e', Mitral E/e', Mitral E/A and Mitral Decel time 2. LA volume 3. RA volume 4. IVC size/compressibility with inspiration 5. RV size/function 1. RV length 2. RV basal width 3. RV FAC % 4. TAPSE 5. S' 6. Tei index 7. TR velocity 8. RVSP 9. TAPSE 10. Longitudinal strain- Basal Longi, Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain 6. Basic valve assessment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females older than 18 years of age * Singleton pregnancy * The patient is physically and mentally able to understand the informed consent and is willing to participate in this study * Able to speak English * Must meet one of the population categories, until each group has reached 20 subjects Exclusion Criteria: * Multiple gestation * History of chronic hypertension or cardiac disease including but not limited to history of heart arrhythmias, congenital heart disease, and use of any cardiac medication (such as beta blockers, ACE inhibitors, calcium channel blockers) prior to pregnancy. * History of medical problems that may contribute to cardiac dysfunction, including but not limited to chronic hypertension, poorly controlled hyperthyroidism and diabetes mellitus.
References
Publications (0)
Data not yet available
No reference posted for this study.