- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310229
Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors
January 16, 2021 updated by: AMHerez, Assiut University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Assiut, Egypt, 71515
- Assiut uni
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of pulmonary arterial pressure
Time Frame: Pulmonary arterial pressure can be measured for a participant using echocardiography in less than one hour
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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.
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Pulmonary arterial pressure can be measured for a participant using echocardiography in less than one hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed abbass, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: J Am Coll Cardiol. 2014 Feb 25;63(7):746. J Am Coll Cardiol. 2014 Feb 25;63(7):746.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 2, 2019
Study Registration Dates
First Submitted
October 11, 2017
First Submitted That Met QC Criteria
October 13, 2017
First Posted (Actual)
October 16, 2017
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 16, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutUn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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