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

NCT06100484 | Completed

• 1 other identifier: RV strain and PET
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension, Pregnancy Induced; Preeclampsia

Keywords

Blood; Pressure; Variabilty; Gestational hypertension; Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• Number of participants that experienced right ventricular remodeling

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

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

Study Arms (2)

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

Echocardiography DIAGNOSTIC_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

Diseased group; Healthy group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women after 20 weeks of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women after 20 weeks of pregnancy

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Mahmoud Elsayed Abdellatif

Aswān, 81511, Egypt

Location

Related Publications (4)

• 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.

  PMID: 21333604 BACKGROUND

• 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.

  PMID: 30143429 BACKGROUND

• 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.

  PMID: 35710191 BACKGROUND

• 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.

  PMID: 32895496 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology resident

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: October 6, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)