Cardiovascular DiseasesNCT05685823
The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
An observational study of Cardiovascular Diseases and Chronic Kidney Diseases, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The objective of this study is to evaluate a group of patients with chronic kidney disease in stages 3-5 by conventional 2D echocardiography, tissue Doppler techniques and speckle tracking - LV GLS and determine the correlation of ultrasound parameters with mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Chronic Kidney Diseases, Fibrosis
- How many people
- 140 participants
- Where
- 1 siteRomania
- Study dates
- 1 Oct 2019to 31 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced chronic kidney disease, pre-dialysis or pre-transplant, in the records of the Clinical Hospital "Dr. C. I. Parhon" Iasi
Who may be able to join
- eGFR < 15 ml/min/1.73m2 (CKD - EPI)
- NYHA class I-II
- Hemodynamic stability
Who cannot join
- age < 18 years old
- poor acoustic window
- atrial fibrillation
- recent Acute Myocardial Infarction
- pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate a group of patients with chronic kidney disease in stages 3-5 by conventional 2D echocardiography, tissue Doppler techniques and speckle tracking - LV GLS and determine the correlation of ultrasound parameters with mortality. Additionally, fibrosis-related biomarkers will be studied in this population.
- Conditions
- Cardiovascular Diseases, Chronic Kidney Diseases, Fibrosis
- Medical subject headings
- Cardiovascular Diseases, Renal Insufficiency, Chronic, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of GLS
Measured: 3 years
All-cause mortality
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Oct 2019
- Primary completion1 Jan 2021
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ureche Carina, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685823
- Sponsor's protocol ID
- EchoESRD
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 17 Jan 2023
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
- ClinicalTrials.gov ID
- NCT05685823
- Acronym / sponsor ID
- EchoESRD
- Conditions
- Cardiovascular Diseases, Chronic Kidney Diseases, Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 17 Jan 2023 (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.
The objective of this study is to evaluate a group of patients with chronic kidney disease in stages 3-5 by conventional 2D echocardiography, tissue Doppler techniques and speckle tracking - LV GLS and determine the correlation of ultrasound parameters with mortality. Additionally, fibrosis-related biomarkers will be studied in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced chronic kidney disease, pre-dialysis or pre-transplant, in the records of the Clinical Hospital "Dr. C. I. Parhon" Iasi
Key inclusion criteria (3 listed)
- eGFR < 15 ml/min/1.73m2 (CKD - EPI)
- NYHA class I-II
- Hemodynamic stability
Key exclusion criteria (5 listed)
- age < 18 years old
- poor acoustic window
- atrial fibrillation
- recent Acute Myocardial Infarction
- pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation of GLS
Time frame: 3 years
All-cause mortality
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular Diseases and Chronic Kidney Diseases, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. 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 Romania. 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?
Results are not available in the source record.
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?
Variation of GLS (time frame: 3 years). The study lists 2 primary outcomes in all. 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 17 Jan 2023.