Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03310229
Collaborator
(none)
80
1
12
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: plain chest x-ray

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 Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 2, 2019

Outcome Measures

Primary Outcome Measures

  1. Measurement of pulmonary arterial pressure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut uni Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Ahmed abbass, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AMHerez, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03310229
Other Study ID Numbers:
  • AssiutUn
First Posted:
Oct 16, 2017
Last Update Posted:
Jan 20, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AMHerez, principal investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2021