NCT04524468

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

August 20, 2020

Last Update Submit

August 22, 2020

Conditions

Keywords

echocardiographyhemodialysisperitoneal dialysisright ventricle

Outcome Measures

Primary Outcomes (1)

  • Estimation of right ventricular function in end-stage renal disease patients

    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

Study Arms (2)

hemodialysis patients

end-stage renal disease patients on hemodialysis

Diagnostic Test: Transthoracic echocardiography

peritoneal dialysis patients

end-stage renal disease patients on peritoneal dialysis

Diagnostic Test: Transthoracic echocardiography

Interventions

Conventional 2-D transthoracic echocardiography was performed to all patients

hemodialysis patientsperitoneal dialysis patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • End-stage renal disease patients on a regular dialysis program
  • Being on dialysis at least 6 months
  • \>18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Research and Training Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Duygu Ersan Demirci, MD

    Antalya Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 24, 2020

Study Start

January 1, 2019

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Locations