Hypertension, Pregnancy InducedNCT06100484
Blood Pressure Variability Effect on Right Ventricular Strain in Women With Hypertensive Disorders With Pregnancy
An observational study of Hypertension, Pregnancy Induced and Preeclampsia, run by Aswan University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the potential effect of blood pressure variability changes on right ventricular strain in pregnant women with gestational hypertension or pre-eclampsia Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pregnancy Induced, Preeclampsia
- What is being tested?
- Echocardiography
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2023to 1 Aug 2024
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women after 20 weeks of pregnancy
Who may be able to join
- Patients with ages equal to or more than 18 years old.
- women with gestational hypertension ( systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation without proteinuria ).
- Women with pre-eclampsia (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation with proteinuria < 300mg /24 h).
Who cannot join
- Pregnancy less than 20 weeks gestation.
- Patients with congenital heart diseases.
- Patients with moderate to severe valvular heart diseases.
- Patients with cardiomyopathy whatever its cause.
- Patients with underlying right ventricular dysfunction.
- Poor image quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Impact of Blood Pressure Variability on Right Ventricular Remodeling in Pregnant Women With Pre-eclampsia or Gestational Hypertension
The goal of this observational study is to learn about the potential effect of blood pressure variability changes on right ventricular strain in pregnant women with gestational hypertension or pre-eclampsia
Read the detailed description
Hypertensive disorders of pregnancy include chronic hypertension, gestational hypertension, pre-eclampsia and chronic hypertension with superimposed pre-eclampsia. Pre-eclampsia, and all hypertensive disorders affect about 5-10% of pregnancies.
The term Blood Pressure Variability is an entity that characterizes the continuous and dynamic fluctuations that occur in blood pressure levels throughout a lifetime.
It encompasses a wide range of blood pressure variations; occurring over seconds or minutes (very short- term BPV), along 24 hours (short- term BPV, usually assessed by ambulatory BP monitoring), and between days (mid- term or day- to- day BPV, assessed with home BP monitoring), Long-term BPV has also been described, including seasonal BP variations and changes between clinic visits over months or years (visit- to- visit BPV).
Studies showed that visit-to-visit BP variability was associated with gestational hypertension and preeclampsia , as well as with risk of adverse birth outcomes in pregnant women without proteinuria or chronic hypertension.
Preeclampsia is a pregnancy-specific disorder that complicates 2-8% of pregnancies worldwide.
Traditionally the condition is diagnosed in the case of de novo development of hypertension (> 140/90 mmHg) and proteinuria during the second half of pregnancy (>20 weeks of gestation).
Preeclampsia (PE) is a life-threatening condition in pregnancy and a major cause of maternal and neonatal morbidity and mortality.
It affects 2-8% of pregnancies that develop serious complications such as eclampsia, hemolysis, elevated liver enzyme levels,thrombocytopenia, and pulmonary edema. These end organ damages usually disappear 12 weeks after delivery.
Gestational hypertension refers to hypertension with onset in the latter part of pregnancy (>20 weeks' gestation) without any other features of preeclampsia, and followed by normalization of the blood pressure postpartum, however, be a harbinger of chronic hypertension later in life as compared with patients who do not have such a history.
There is an association between RV longitudinal strain and functional capacity in hypertensive patients. as well as the strong relationship between RV longitudinal strain and cardiovascular mortality and morbidity in a wide range of cardiovascular conditions.
Over the past few decades, there has been a lot of research done on left ventricular remodeling in hypertensive diseases of pregnancy, especially in gestational hypertension and preeclampsia.However, anatomical, functional, and mechanical changes to the right ventricle are still largely unclear. The limited data are also contradictory because some authors reported significant functional changes in the form of increased RV diameter, elevated pulmonary pressure, and decreased RV longitudinal strain. while other studies showed no difference in RV structure and function between normotensive controls and pregnant women with hypertensive disorders.
In the current study, we are going to assess the impact of gestational hypertension and preeclampsia on RV remodeling. If remodeling occurs, we are going to assess RV recovery post partum.
- Conditions
- Hypertension, Pregnancy Induced, Preeclampsia
- Being tested
- Echocardiography
- Keywords
- Blood, Pressure, Variabilty, Gestational hypertension, Pre-eclampsia
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Two-dimensional RV strain imaging will be performed by using three consecutive cardiac cycles of 2D images in the apical four-chamber view to assess RV-GLS
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Pregnant women above 20 weeks of pregnancy with no hypertensive disorders with pregnancy Receives: Diagnostic Test: Echocardiography | |
| Diseased group | Pregnant women above 20 weeks of pregnancy with gestational hypertension or pre-eclampsia Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experienced right ventricular remodeling
Assessment of right ventricular strain via 2D Echocardiography and Speckle tracking
Measured: From Baseline at time of examination till 3 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start6 Oct 2023
- Primary completion30 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy InducedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elsayed Abdellatif, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100484
- Sponsor's protocol ID
- RV strain and PET
- Status last verified
- Aug 2024
- First submitted
- 20 Oct 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18.
PubMed 21333604Chen SSM, Leeton L, Castro JM, Dennis AT. Myocardial tissue characterisation and detection of myocardial oedema by cardiovascular magnetic resonance in women with pre-eclampsia: a pilot study. Int J Obstet Anesth. 2018 Nov;36:56-65. doi: 10.1016/j.ijoa.2018.07.004. Epub 2018 Aug 2.
PubMed 30143429Levine LD, Ky B, Chirinos JA, Koshinksi J, Arany Z, Riis V, Elovitz MA, Koelper N, Lewey J. Prospective Evaluation of Cardiovascular Risk 10 Years After a Hypertensive Disorder of Pregnancy. J Am Coll Cardiol. 2022 Jun 21;79(24):2401-2411. doi: 10.1016/j.jacc.2022.03.383.
PubMed 35710191Liu J, Yang L, Teng H, Cao Y, Wang J, Han B, Tao L, Zhong B, Wang F, Xiao C, Wan Z, Yin J. Visit-to-visit blood pressure variability and risk of adverse birth outcomes in pregnancies in East China. Hypertens Res. 2021 Feb;44(2):239-249. doi: 10.1038/s41440-020-00544-7. Epub 2020 Sep 7.
PubMed 32895496
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Impact of Blood Pressure Variability on Right Ventricular Remodeling in Pregnant Women With Pre-eclampsia or Gestational Hypertension
- ClinicalTrials.gov ID
- NCT06100484
- Acronym / sponsor ID
- RV strain and PET
- Conditions
- Hypertension, Pregnancy Induced, Preeclampsia
- Keywords
- Blood, Pressure, Variabilty, Gestational hypertension, Pre-eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 25 Oct 2023 (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.
The goal of this observational study is to learn about the potential effect of blood pressure variability changes on right ventricular strain in pregnant women with gestational hypertension or pre-eclampsia
Detailed description
Hypertensive disorders of pregnancy include chronic hypertension, gestational hypertension, pre-eclampsia and chronic hypertension with superimposed pre-eclampsia. Pre-eclampsia, and all hypertensive disorders affect about 5-10% of pregnancies.
The term Blood Pressure Variability is an entity that characterizes the continuous and dynamic fluctuations that occur in blood pressure levels throughout a lifetime.
It encompasses a wide range of blood pressure variations; occurring over seconds or minutes (very short- term BPV), along 24 hours (short- term BPV, usually assessed by ambulatory BP monitoring), and between days (mid- term or day- to- day BPV, assessed with home BP monitoring), Long-term BPV has also been described, including seasonal BP variations and changes between clinic visits over months or years (visit- to- visit BPV).
Studies showed that visit-to-visit BP variability was associated with gestational hypertension and preeclampsia , as well as with risk of adverse birth outcomes in pregnant women without proteinuria or chronic hypertension.
Preeclampsia is a pregnancy-specific disorder that complicates 2-8% of pregnancies worldwide.
Traditionally the condition is diagnosed in the case of de novo development of hypertension (> 140/90 mmHg) and proteinuria during the second half of pregnancy (>20 weeks of gestation).
Preeclampsia (PE) is a life-threatening condition in pregnancy and a major cause of maternal and neonatal morbidity and mortality.
It affects 2-8% of pregnancies that develop serious complications such as eclampsia, hemolysis, elevated liver enzyme levels,thrombocytopenia, and pulmonary edema. These end organ damages usually disappear 12 weeks after delivery.
Gestational hypertension refers to hypertension with onset in the latter part of pregnancy (>20 weeks' gestation) without any other features of preeclampsia, and followed by normalization of the blood pressure postpartum, however, be a harbinger of chronic hypertension later in life as compared with patients who do not have such a history.
There is an association between RV longitudinal strain and functional capacity in hypertensive patients. as well as the strong relationship between RV longitudinal strain and cardiovascular mortality and morbidity in a wide range of cardiovascular conditions.
Over the past few decades, there has been a lot of research done on left ventricular remodeling in hypertensive diseases of pregnancy, especially in gestational hypertension and preeclampsia.However, anatomical, functional, and mechanical changes to the right ventricle are still largely unclear. The limited data are also contradictory because some authors reported significant functional changes in the form of increased RV diameter, elevated pulmonary pressure, and decreased RV longitudinal strain. while other studies showed no difference in RV structure and function between normotensive controls and pregnant women with hypertensive disorders.
In the current study, we are going to assess the impact of gestational hypertension and preeclampsia on RV remodeling. If remodeling occurs, we are going to assess RV recovery post partum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Diagnostic Test: EchocardiographyPregnant women above 20 weeks of pregnancy with no hypertensive disorders with pregnancy |
| Diseased group | – | Diagnostic Test: EchocardiographyPregnant women above 20 weeks of pregnancy with gestational hypertension or pre-eclampsia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women after 20 weeks of pregnancy
Key inclusion criteria (3 listed)
- Patients with ages equal to or more than 18 years old.
- women with gestational hypertension ( systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation without proteinuria ).
- Women with pre-eclampsia (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation with proteinuria < 300mg /24 h).
Key exclusion criteria (6 listed)
- Pregnancy less than 20 weeks gestation.
- Patients with congenital heart diseases.
- Patients with moderate to severe valvular heart diseases.
- Patients with cardiomyopathy whatever its cause.
- Patients with underlying right ventricular dysfunction.
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 |
|---|---|---|
| EchocardiographyTwo-dimensional RV strain imaging will be performed by using three consecutive cardiac cycles of 2D images in the apical four-chamber view to assess RV-GLS | Diagnostic test | Diseased group, Healthy group |
Primary outcome
Number of participants that experienced right ventricular remodeling
Time frame: From Baseline at time of examination till 3 months post-partum
Assessment of right ventricular strain via 2D Echocardiography and Speckle tracking
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 6 Aug 2024.
- Background: PubMed 21333604Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18.
- Background: PubMed 30143429Chen SSM, Leeton L, Castro JM, Dennis AT. Myocardial tissue characterisation and detection of myocardial oedema by cardiovascular magnetic resonance in women with pre-eclampsia: a pilot study. Int J Obstet Anesth. 2018 Nov;36:56-65. doi: 10.1016/j.ijoa.2018.07.004. Epub 2018 Aug 2.
- Background: PubMed 35710191Levine LD, Ky B, Chirinos JA, Koshinksi J, Arany Z, Riis V, Elovitz MA, Koelper N, Lewey J. Prospective Evaluation of Cardiovascular Risk 10 Years After a Hypertensive Disorder of Pregnancy. J Am Coll Cardiol. 2022 Jun 21;79(24):2401-2411. doi: 10.1016/j.jacc.2022.03.383.
- Background: PubMed 32895496Liu J, Yang L, Teng H, Cao Y, Wang J, Han B, Tao L, Zhong B, Wang F, Xiao C, Wan Z, Yin J. Visit-to-visit blood pressure variability and risk of adverse birth outcomes in pregnancies in East China. Hypertens Res. 2021 Feb;44(2):239-249. doi: 10.1038/s41440-020-00544-7. Epub 2020 Sep 7.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension, Pregnancy Induced and Preeclampsia, run by Aswan University at 1 site in Egypt.
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 3 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 6 Aug 2024. 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 Egypt. 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?
Number of participants that experienced right ventricular remodeling (time frame: From Baseline at time of examination till 3 months post-partum). 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 NCT06100484, which also lists 4 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 6 Aug 2024.