Chronic Kidney DiseasesNCT06221891
Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography
An observational study of Chronic Kidney Diseases and Left Ventricular Systolic Dysfunction, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(CKD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Left Ventricular Systolic Dysfunction
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.
Who may be able to join
- Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.
- LVEF≥50%.
Who cannot join
- Patients with primary hypertension, diabetes and congenital heart disease.
- Patients who are pregnant or lactating.
- Patients with the blurry ultrasound images.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Qing Ye, 15625144037, 2530774844@qq.com
About this study
The goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(CKD). The main questions it aims to answer are:
- If first-phase ejection fraction（EF1）could early detect the left ventricular systolic dysfunction in patients with CKD.
- Whether EF1 can detect left ventricular systolic dysfunction in patients with CKD more sensitively than speckle-tracking echocardiography and myocardial work.
Participants will need to cooperate to do an echocardiography. Researchers will compare healthy volunteers and patients with CKD to see if EF1 could early detect the left ventricular systolic dysfunction.
- Keywords
- first phase ejection fraction;left ventricular systolic dysfunction;echocardiography;chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | This group contains the patients with chronic kidney disease. | |
| control group | This group contains the healthy adults. |
What is being measured
The primary outcome is the main question the study is designed to answer.
first-phase ejection fraction
an ultrasound indicator used to assess early left ventricular systolic function
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221891
- Sponsor's protocol ID
- ZDWY.CSK.006
- Status last verified
- Apr 2024
- First submitted
- 16 Jan 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography
- ClinicalTrials.gov ID
- NCT06221891
- Acronym / sponsor ID
- ZDWY.CSK.006
- Keywords
- first phase ejection fraction;left ventricular systolic dysfunction;echocardiography;chronic kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jan 2024 (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 goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(CKD). The main questions it aims to answer are:
- If first-phase ejection fraction（EF1）could early detect the left ventricular systolic dysfunction in patients with CKD.
- Whether EF1 can detect left ventricular systolic dysfunction in patients with CKD more sensitively than speckle-tracking echocardiography and myocardial work.
Participants will need to cooperate to do an echocardiography. Researchers will compare healthy volunteers and patients with CKD to see if EF1 could early detect the left ventricular systolic dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | –This group contains the patients with chronic kidney disease. |
| control group | – | –This group contains the healthy adults. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.
Key inclusion criteria (2 listed)
- Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.
- LVEF≥50%.
Key exclusion criteria (3 listed)
- Patients with primary hypertension, diabetes and congenital heart disease.
- Patients who are pregnant or lactating.
- Patients with the blurry ultrasound images.
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
first-phase ejection fraction
Time frame: 1 hour
an ultrasound indicator used to assess early left ventricular systolic function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
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 Chronic Kidney Diseases and Left Ventricular Systolic Dysfunction, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 2 inclusion and 3 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 11 Apr 2024. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first-phase ejection fraction (time frame: 1 hour). 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 11 Apr 2024.