NCT03310229

Brief Summary

High mortality rates due to cardiovascular disease in end-stage renal disease patients been described by epidemiological and clinical studies. It accounts for approximately 50 percent of deaths in dialysis patients. Although controversial, this may be due to the presence of excess vascular calcification particularly in the form of extensive coronary artery calcification which can be observed even in very young dialysis patients. It was suggested that abnormalities of the right ventricular function in patients with end-stage renal disease were largely due to pulmonary hypertension which usually develops secondary to pulmonary artery calcifications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

October 11, 2017

Last Update Submit

January 16, 2021

Conditions

Keywords

cardiovascular complications

Outcome Measures

Primary Outcomes (1)

  • Measurement of pulmonary arterial pressure

    The participants will be subjected to a trans-thoracic echocardiography to measure pulmonary arterial pressure to detect and know the frequency of pulmonary hypertension in our haemodialysis patients for adequate care and early treatment and to study its possible risk factors to decrease morbidity and mortality.

    Pulmonary arterial pressure can be measured for a participant using echocardiography in less than one hour

Interventions

the participants will be subjected to plain chest x-ray with other tools to help diagnose pulmonary hypertension in haemodialysis patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

80 subjects undergoing haemodialysis for more than one year will be subjected to some diagnostic tools to detect and know the frequency of pulmonary hypertension(PH) among those patients.

You may qualify if:

  • haemodialsis patients aged from 18 to 60 years old
  • haemodialysis patients are on regular haemodialysis for more than one year

You may not qualify if:

  • All patients with a high probability of secondary pulmonary hypertension, those with the following history: chronic obstructive pulmonary disease, pulmonary embolism congenital heart disease, heart failure, Bilharziasis plus active HIV infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut uni

Asyut, 71515, Egypt

Location

Related Publications (4)

  • Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Gomez Sanchez MA, Krishna Kumar R, Landzberg M, Machado RF, Olschewski H, Robbins IM, Souza R. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D34-41. doi: 10.1016/j.jacc.2013.10.029.

    PMID: 24355639BACKGROUND
  • Nitta K, Ogawa T. Vascular calcification in end-stage renal disease patients. Contrib Nephrol. 2015;185:156-67. doi: 10.1159/000380980. Epub 2015 May 19.

    PMID: 26023025BACKGROUND
  • Li Z, Liu S, Liang X, Wang W, Fei H, Hu P, Chen Y, Xu L, Li R, Shi W. Pulmonary hypertension as an independent predictor of cardiovascular mortality and events in hemodialysis patients. Int Urol Nephrol. 2014 Jan;46(1):141-9. doi: 10.1007/s11255-013-0486-z. Epub 2013 Jun 21.

  • Stompor T. An overview of the pathophysiology of vascular calcification in chronic kidney disease. Perit Dial Int. 2007 Jun;27 Suppl 2:S215-22.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Ahmed abbass

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 16, 2017

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 2, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations