Transthoracic EchocardiographyNCT04524468
Right Ventricular Function in End-stage Renal Disease Patients
An observational study of Transthoracic Echocardiography and Hemodialysis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transthoracic Echocardiography, Hemodialysis
- What is being tested?
- Transthoracic echocardiography
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: End-stage renal disease patients on a regular dialysis program at least 6 months
Who may be able to join
- End-stage renal disease patients on a regular dialysis program
- Being on dialysis at least 6 months
- >18 years old
Who cannot join
- 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
Show all 12Show fewer
- Chronic obstructive pulmonary disease
- Interstitial lung diseases
- Connective tissue disorders
- Chronic thromboembolic disease
- Congenital left-to-right shunt
- Primary pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Research and Training Hospital
Antalya
About this study
Official title: 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.
Read the 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.
- Conditions
- Transthoracic Echocardiography, Hemodialysis
- Being tested
- Transthoracic echocardiography
- Keywords
- echocardiography, hemodialysis, peritoneal dialysis, right ventricle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
Conventional 2-D transthoracic echocardiography was performed to all patients
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis patients | end-stage renal disease patients on hemodialysis Receives: Diagnostic Test: Transthoracic echocardiography | |
| peritoneal dialysis patients | end-stage renal disease patients on peritoneal dialysis Receives: Diagnostic Test: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthoracic EchocardiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Ersan Demirci, Antalya Training and Research Hospital
- Investigators
- Duygu Ersan Demirci, MD, Principal investigator, Antalya Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524468
- Sponsor's protocol ID
- 2019-398
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Dialysis Modalities on Right Ventricular Function in End-stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT04524468
- Acronym / sponsor ID
- 2019-398
- Conditions
- Transthoracic Echocardiography, Hemodialysis
- Keywords
- echocardiography, hemodialysis, peritoneal dialysis, right ventricle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodialysis patients | – | Diagnostic Test: Transthoracic echocardiographyend-stage renal disease patients on hemodialysis |
| peritoneal dialysis patients | – | Diagnostic Test: Transthoracic echocardiographyend-stage renal disease patients on peritoneal dialysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients on a regular dialysis program at least 6 months
Key inclusion criteria (3 listed)
- End-stage renal disease patients on a regular dialysis program
- Being on dialysis at least 6 months
- >18 years old
Key exclusion criteria (12 listed)
- Ischemic heart disease
- Left ventricular systolic dysfunction with an ejection fraction (EF) of less than 55 %
- Valvulopathy
- Left bundle branch block
- Atrial fibrilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiographyConventional 2-D transthoracic echocardiography was performed to all patients | Diagnostic test | hemodialysis patients, peritoneal dialysis patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu Ersan Demirci, MD principal investigator
Antalya Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthoracic Echocardiography and Hemodialysis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of right ventricular function in end-stage renal disease patients (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.