Clinical trial NCT03310229: Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors
Official title: Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: cardiovascular complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of pulmonary arterial pressure
timeFrame: Pulmonary arterial pressure can be measured for a participant using echocardiography in less than one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut uni
Study officials:
affiliation: Assiut University
name: Ahmed abbass
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: Stompor T. An overview of the pathophysiology of vascular calcification in chronic kidney disease. Perit Dial Int. 2007 Jun;27 Suppl 2:S215-22.