Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors

Pulmonary Hypertension Clinical Trial

Official title:

Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310229
• Other study ID #: AssiutUn
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: December 2, 2019

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Primary whose mechanisms are incompletely known, is another vascular disease entity recently described in chronic kidney disease particularly in patients undergoing haemodialysis. It corresponds to 5th subtype of World Symposium on Pulmonary Hypertension classification established in 2008 in Dana Point and updated in 2013 in Nice. Pulmonary hypertension is defined by Pulmonary arterial pressure mean ≥25 mm Hg at rest measured by right heart catheterization. Its pathophysiological mechanism is controversy maybe explained by vascular calcification, blood flow in arteriovenous fistula and fluid overload. Primary pulmonary hypertension is a major problem of haemodialysis patients because of its high prevalence, sometimes reaching 68% and by its significant morbidity and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 80 haemodialsis patients aged from 18 to 60 years old

• 80 haemodialysis patients are on regular haemodialysis for more than one year

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut uni	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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- — View Citation

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. Review. — View Citation

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. Review. Erratum in: J Am Coll Cardiol. 2014 Feb 25;63(7):746. Erratum in: J Am Coll Cardiol. 2014 Feb 25;63(7):746. — View Citation

Stompór T. An overview of the pathophysiology of vascular calcification in chronic kidney disease. Perit Dial Int. 2007 Jun;27 Suppl 2:S215-22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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