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

Sponsor

Aswan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06100484

Collaborator

(none)

Enrollment

Location

11.9

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pregnancy Induced Preeclampsia	Diagnostic Test: Echocardiography

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

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Potential Impact of Blood Pressure Variability on Right Ventricular Remodeling in Pregnant Women With Pre-eclampsia or Gestational Hypertension

Actual Study Start Date :

Oct 6, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Healthy group Pregnant women above 20 weeks of pregnancy with no hypertensive disorders with pregnancy	Diagnostic Test: Echocardiography 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
Diseased group Pregnant women above 20 weeks of pregnancy with gestational hypertension or pre-eclampsia	Diagnostic Test: Echocardiography 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

Arm

Intervention/Treatment

Healthy group

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

Diagnostic Test: Echocardiography

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

Diseased group

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

Diagnostic Test: Echocardiography

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

Outcome Measures

Primary Outcome Measures

Number of participants that experienced right ventricular remodeling [From Baseline at time of examination till 3 months post-partum]
Assessment of right ventricular strain via 2D Echocardiography and Speckle tracking

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).