Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT04892745 - Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
Not yet recruiting NCT04925674 - Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis. Phase 1
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Withdrawn NCT02904343 - Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study N/A
Withdrawn NCT01855334 - L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD Phase 4
Completed NCT01700465 - Estimating and Predicting Hemodynamic Changes During Hemodialysis N/A
Recruiting NCT01195519 - The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis N/A
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00527774 - Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00850252 - Use of a Lifeline Graft in the A-V Shunt Model Phase 1/Phase 2
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Recruiting NCT06351007 - Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) N/A
Withdrawn NCT03664141 - Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study) Phase 3
Completed NCT03909698 - Antibiotic Dosing in Patients on Intermittent Hemodialysis
Recruiting NCT03311321 - Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients N/A
Recruiting NCT06098924 - HD Patients' Depression and Happiness
Recruiting NCT03419923 - Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage N/A