Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03310229
Recruitment Status : Not yet recruiting
First Posted : October 16, 2017
Last Update Posted : December 28, 2017
Information provided by (Responsible Party):
AMHerez, Assiut University

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
Pulmonary Hypertension 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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03310229

Contact: mohamed sobh 00201069272662
Contact: Essam Abdel Azizi 00201009699081

Sponsors and Collaborators
Assiut University
Principal Investigator: Ahmed abbass Assiut University

Publications of Results:
Other Publications:
Responsible Party: AMHerez, principal investigator, Assiut University Identifier: NCT03310229     History of Changes
Other Study ID Numbers: AssiutUn
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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, Assiut University:
cardiovascular complications

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases