Diastolic Dysfunction 2025

N/ACompletedNCT07190846

University Tunis El Manar80 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Preeclampsia Severe Preeclampsia

Interventions

No Intervention (Observational Echocardiographic Evaluation)OTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Maternity and Neonatology Center of Tunis

Tunis, Tunisia

Outcomes

Primary Outcomes

Prevalence of Left Ventricular Diastolic Dysfunction in Preeclamptic Women

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.

Time frame: At baseline, during third-trimester pregnancy hospital evaluation.

Data from ClinicalTrials.gov

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