- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04524468
Right Ventricular Function in End-stage Renal Disease Patients
The Impact of Different Dialysis Modalities on Right Ventricular Function in End-stage Renal Disease Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cardiovascular diseases (CVD) are the main causes of death in patients undergoing dialysis. Right ventricular (RV) dysfunction is one of the major predictors of mortality and heart failure in this patient group. It has been shown that patients undergoing hemodialysis (HD) which is usually carried out via a surgically created arteriovenous fistula (AVF) have an increased risk for pulmonary hypertension and poorer right ventricular function compared with healthy controls . However, there are few data comparing the patients undergoing HD and peritoneal dialysis (PD), in terms of echocardiographic right ventricular function.
The aim of the present study was to elucidate the impact of both long term PD and HD therapy via brachial AVF on RV function in patients with preserved left ventricular (LV) function.
Patients undergoing dialysis were grouped as follows: 46 patients on PD and 37 patients on HD with brachial AVF. All of the study patients underwent transthoracic echocardiography. Left and right ventricular parameters were compared between two groups.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Antalya, Turkey
- Antalya Research and Training Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- End-stage renal disease patients on a regular dialysis program
- Being on dialysis at least 6 months
- >18 years old
Exclusion Criteria:
- Ischemic heart disease
- Left ventricular systolic dysfunction with an ejection fraction (EF) of less than 55 %
- Valvulopathy
- Left bundle branch block
- Atrial fibrilation
- Previous renal transplantation
- Chronic obstructive pulmonary disease
- Interstitial lung diseases
- Connective tissue disorders
- Chronic thromboembolic disease
- Congenital left-to-right shunt
- Primary pulmonary hypertension
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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hemodialysis patients
end-stage renal disease patients on hemodialysis
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Conventional 2-D transthoracic echocardiography was performed to all patients
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peritoneal dialysis patients
end-stage renal disease patients on peritoneal dialysis
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Conventional 2-D transthoracic echocardiography was performed to all patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimation of right ventricular function in end-stage renal disease patients
Time Frame: 1 week
|
Transthoracic echocardiography was performed to end-stage renal disease patients on hemodialysis and peritoneal dialysis for at least 6 months.
Tricuspid annular plane systolic excursion (TAPSE), right ventricular fractional area change (RV FAC), Right ventricular myocardial performance index (RV MPI) and right ventricular lateral peak annular systolic velocity (Sa) were measured to estimate right ventricular function.
|
1 week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-398
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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