Diastolic Dysfunction 2025

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preeclampsia Severe Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Preeclampsia Group

Pregnant women in the third trimester diagnosed with preeclampsia (mostly severe forms), aged 18-45 years, without pre-existing cardiovascular disease or other exclusion criteria.

No Intervention (Observational Echocardiographic Evaluation)

Intervention Type OTHER

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

Control Group

Normotensive pregnant women in the third trimester, aged 18-45 years, without cardiovascular disease or other exclusion criteria.

No Intervention (Observational Echocardiographic Evaluation)

Intervention Type OTHER

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

Interventions

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No 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes