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Diastolic Dysfunction 2025

Diastolic Dysfunction in the Pregnant Woman With Preeclampsia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07190846
Enrollment
80
Registered
2025-09-24
Start date
2025-03-01
Completion date
2025-07-31
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia, Severe Preeclampsia

Keywords

Diastolic dysfunction, Echocardiography, Maternal heart function, Left ventricular relaxation, Pregnancy hypertension, Cardio-obstetrics, Maternal cardiovascular risk

Brief summary

This is a prospective observational study conducted at the Maternity and Neonatology Center of Tunis to evaluate cardiac diastolic function in women with preeclampsia compared with normotensive pregnant women. A total of 80 pregnant women in the third trimester were enrolled, including 40 with preeclampsia (mostly severe forms) and 40 healthy controls. All participants underwent standardized transthoracic echocardiography to assess left ventricular diastolic function according to the 2016 ASE/EACVI recommendations.

Detailed description

Preeclampsia is a major hypertensive disorder of pregnancy associated with increased maternal morbidity and mortality, as well as long-term cardiovascular risk. Cardiac remodeling in this context is characterized by increased vascular stiffness and concentric left ventricular hypertrophy, which may lead to subclinical diastolic dysfunction despite preserved systolic function. This prospective observational study was designed to evaluate left ventricular diastolic function in women with preeclampsia compared to normotensive pregnant women. Eighty participants in the third trimester of pregnancy were included: 40 diagnosed with preeclampsia (mainly severe forms) and 40 normotensive controls. Women with pre-existing cardiovascular disease, diabetes, renal impairment, or multiple pregnancies were excluded. All participants underwent standardized echocardiographic evaluation in accordance with the 2016 recommendations of the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI). Diastolic function was assessed based on transmitral Doppler indices (E and A waves, E/A ratio), tissue Doppler imaging (septal and lateral e' velocities), E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity.

Interventions

OTHERNo Intervention (Observational Echocardiographic Evaluation)

This is an observational study. No therapeutic intervention is administered. Participants undergo standard echocardiographic assessment of left ventricular diastolic function during pregnancy.

Sponsors

University Tunis El Manar
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women aged 18-45 years * Third trimester of pregnancy * Group A: women diagnosed with preeclampsia according to international criteria (blood pressure ≥ 140/90 mmHg after 20 weeks with proteinuria or signs of severity) * Group B (controls): normotensive pregnant women without proteinuria or cardiovascular disease * Signed informed consent

Exclusion criteria

* Known pre-existing cardiovascular disease (structural heart disease, heart failure, chronic hypertension complicated) * Left ventricular ejection fraction \< 45% * Pre-gestational diabetes * Chronic kidney disease * Multiple pregnancy * Other severe comorbidities that could affect cardiac function independently of preeclampsia

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Left Ventricular Diastolic Dysfunction in Preeclamptic WomenAt baseline, during third-trimester pregnancy hospital evaluation.Echocardiographic assessment of diastolic function according to ASE/EACVI 2016 criteria, including parameters E, A, E/A ratio, septal and lateral e' velocities, E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity.

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026