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Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors

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ClinicalTrials.gov Identifier: NCT03310229
Recruitment Status : Not yet recruiting
First Posted : October 16, 2017
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
AMHerez, Assiut University

October 11, 2017
October 16, 2017
December 28, 2017
June 30, 2018
December 30, 2018   (Final data collection date for primary outcome measure)
Measurement of pulmonary arterial pressure [ Time Frame: Pulmonary arterial pressure can be measured for a participant using echocardiography in less than one hour ]
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.
Same as current
Complete list of historical versions of study NCT03310229 on ClinicalTrials.gov Archive Site
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Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors
Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors
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.
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.
Observational
Observational Model: Other
Time Perspective: Cross-Sectional
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Probability Sample
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.
Pulmonary Hypertension
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Same as current
June 30, 2019
December 30, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: mohamed sobh 00201069272662 hamed.msobh@aun.edu.eg
Contact: Essam Abdel Azizi 00201009699081 ahmed_kawser@aun.edu.eg
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NCT03310229
AssiutUn
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
AMHerez, Assiut University
Assiut University
Not Provided
Principal Investigator: Ahmed abbass Assiut University
Assiut University
December 2017