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CompletedNCT06100484Updated Aug 6, 2024

Blood Pressure Variability Effect on Right Ventricular Strain in Women With Hypertensive Disorders With Pregnancy

An observational study in Hypertension, Pregnancy Induced and Preeclampsia, sponsored by Aswan University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Aswan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 50 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Hypertension, Pregnancy Induced
  • Preeclampsia

Keywords

  • Blood
  • Pressure
  • Variabilty
  • Gestational hypertension
  • Pre-eclampsia
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In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 60 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Aswan University is the lead sponsor of 47 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pregnant women after 20 weeks of pregnancy

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy group

    Pregnant women above 20 weeks of pregnancy with no hypertensive disorders with pregnancy

    Diagnostic Test: Echocardiography

  • Diseased group

    Pregnant women above 20 weeks of pregnancy with gestational hypertension or pre-eclampsia

    Diagnostic Test: Echocardiography

Interventions

  • Diagnostic testEchocardiography

    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

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What researchers measure

Primary outcomes

  1. Number of participants that experienced right ventricular remodeling

    Assessment of right ventricular strain via 2D Echocardiography and Speckle tracking

    Time frame: From Baseline at time of examination till 3 months post-partum

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Study locations

1 site
  • Mahmoud Elsayed Abdellatif
    Aswan, 81511, Egypt
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References and documents

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 21333604 ↗
  • Chen 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 30143429 ↗
  • Levine 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 35710191 ↗
  • Liu 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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06100484
Lead sponsor
Aswan University
Responsible party
Mahmoud Elsayed Abdellatif (Cardiology resident, Aswan University) — Principal investigator
First posted
Oct 25, 2023
Start date
Oct 6, 2023
Primary completion
Jul 30, 2024
Completion
Aug 1, 2024
Last update
Aug 6, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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