PreeclampsiaNCT07190846
Diastolic Dysfunction 2025
An observational study of Preeclampsia and Severe Preeclampsia, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Severe Preeclampsia
- How many people
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2025to 31 Jul 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diastolic Dysfunction in the Pregnant Woman With Preeclampsia
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.
Read the 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.
- Conditions
- Preeclampsia, Severe Preeclampsia
- Being tested
- No Intervention (Observational Echocardiographic Evaluation)
- Keywords
- Diastolic dysfunction, Echocardiography, Maternal heart function, Left ventricular relaxation, Pregnancy hypertension, Cardio-obstetrics, Maternal cardiovascular risk
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Intervention (Observational Echocardiographic Evaluation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, during third-trimester pregnancy hospital evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Mar 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Ben marzouk sofiene, Principal investigator, Maternity and Neonatology Center of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190846
- Sponsor's protocol ID
- 05/2025
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet decided whether individual participant data (IPD) from this study will be shared. Decisions regarding data sharing will depend on future institutional policies, ethical considerations, and requests from qualified researchers.
Publications
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.
PubMed 28906533Guirguis 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.
PubMed 26597754Vaught 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.
PubMed 29957219Melchiorre 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.
PubMed 21098311Nagueh 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.
PubMed 27037982
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Dysfunction in the Pregnant Woman With Preeclampsia
- ClinicalTrials.gov ID
- NCT07190846
- Acronym / sponsor ID
- 05/2025
- Conditions
- Preeclampsia, Severe Preeclampsia
- Keywords
- Diastolic dysfunction, Echocardiography, Maternal heart function, Left ventricular relaxation, Pregnancy hypertension, Cardio-obstetrics, Maternal cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia Group | – | Other: No Intervention (Observational Echocardiographic Evaluation)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. |
| Control Group | – | Other: No Intervention (Observational Echocardiographic Evaluation)Normotensive pregnant women in the third trimester, aged 18-45 years, without cardiovascular disease or other exclusion criteria. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control Group, Preeclampsia Group |
Primary outcome
Prevalence of Left Ventricular Diastolic Dysfunction in Preeclamptic Women
Time frame: At 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Results publication: PubMed 28906533Soma-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.
- Results publication: PubMed 26597754Guirguis 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.
- Results publication: PubMed 29957219Vaught 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.
- Results publication: PubMed 21098311Melchiorre 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.
- Results publication: PubMed 27037982Nagueh 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.
- Individual participant dataSharing planned: Undecided. The investigators have not yet decided whether individual participant data (IPD) from this study will be shared. Decisions regarding data sharing will depend on future institutional policies, ethical considerations, and requests from qualified researchers.
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Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben marzouk sofiene principal investigator
Maternity and Neonatology Center of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Severe Preeclampsia, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Left Ventricular Diastolic Dysfunction in Preeclamptic Women (time frame: At baseline, during third-trimester pregnancy hospital evaluation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07190846, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.