Diastolic Dysfunction 2025

NCT07190846 | Completed

• 1 other identifier: 05/2025
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Severe Preeclampsia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline, during third-trimester pregnancy hospital evaluation.

Study Arms (2)

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.

Other: No Intervention (Observational Echocardiographic Evaluation)

Control Group

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

Other: No Intervention (Observational Echocardiographic Evaluation)

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.

Control Group; Preeclampsia Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in the third trimester recruited at the Center of Maternity and Neonatology of Tunis, including 40 with preeclampsia (mainly severe forms) and 40 normotensive controls.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Maternity and Neonatology Center of Tunis

Tunis, 1007, Tunisia

Location

Related Publications (5)

• Soma-Pillay P, Louw MC, Adeyemo AO, Makin J, Pattinson RC. Cardiac diastolic function after recovery from pre-eclampsia. Cardiovasc J Afr. 2018 Jan/Feb 23;29(1):26-31. doi: 10.5830/CVJA-2017-031. Epub 2017 Aug 31.

  PMID: 28906533 RESULT

• Guirguis GF, Aziz MM, Boccia Liang C, Williams SF, Apuzzio JJ, Bilinski R, Mornan AJ, Shah LP. Is preeclampsia an independent predictor of diastolic dysfunction? A retrospective cohort study. Pregnancy Hypertens. 2015 Oct;5(4):359-61. doi: 10.1016/j.preghy.2015.10.001. Epub 2015 Oct 9.

  PMID: 26597754 RESULT

• Vaught AJ, Kovell LC, Szymanski LM, Mayer SA, Seifert SM, Vaidya D, Murphy JD, Argani C, O'Kelly A, York S, Ouyang P, Mukherjee M, Zakaria S. Acute Cardiac Effects of Severe Pre-Eclampsia. J Am Coll Cardiol. 2018 Jul 3;72(1):1-11. doi: 10.1016/j.jacc.2018.04.048.

  PMID: 29957219 RESULT

• Melchiorre K, Sutherland GR, Baltabaeva A, Liberati M, Thilaganathan B. Maternal cardiac dysfunction and remodeling in women with preeclampsia at term. Hypertension. 2011 Jan;57(1):85-93. doi: 10.1161/HYPERTENSIONAHA.110.162321. Epub 2010 Nov 22.

  PMID: 21098311 RESULT

• Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.

  PMID: 27037982 RESULT

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ben marzouk sofiene

  Maternity and Neonatology Center of Tunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Critical Care, Principal Investigator

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 24, 2025
• Study Start: March 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

TU (1)