Right Ventricular Function in End-stage Renal Disease Patients

August 22, 2020 updated by: Duygu Ersan Demirci, Antalya Training and Research Hospital

The Impact of Different Dialysis Modalities on Right Ventricular Function in End-stage Renal Disease Patients

Right ventricular (RV) dysfunction is a major cause of heart failure and mortality in end-stage renal disease (ESRD) patients. The aim of the study was to evaluate the long-term impacts of different dialysis modalities on RV function assessed by conventional echocardiography in ESRD patients with preserved left ventricular function. The study included 83 ESRD patients grouped as follows: peritoneal dialysis (PD; n=46) and hemodialysis with brachial arterio-venous fistula (HD; n=37). Conventional echocardiography including 2D and tissue Doppler imaging was performed in all patients. Echocardiographic parameters were compared between groups.

Study Overview

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

Observational

Enrollment (Actual)

83

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

      • Antalya, Turkey
        • Antalya Research and Training Hospital

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

End-stage renal disease patients on a regular dialysis program at least 6 months

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hemodialysis patients
end-stage renal disease patients on hemodialysis
Conventional 2-D transthoracic echocardiography was performed to all patients
peritoneal dialysis patients
end-stage renal disease patients on peritoneal dialysis
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

This is where you will find people and organizations involved with this study.

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)

January 1, 2019

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (ACTUAL)

August 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 22, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

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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