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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04524468
Other study ID # 2019-398
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date July 1, 2020

Study information

Verified date August 2020
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date July 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Transthoracic echocardiography
Conventional 2-D transthoracic echocardiography was performed to all patients

Locations

Country Name City State
Turkey Antalya Research and Training Hospital Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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