Chronic Kidney Disease Stage 5NCT06542016
An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients
An observational study of Chronic Kidney Disease Stage 5 and Dialysis, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
Cardiovascular Disease (CVD) is the main complication and the most important cause of death in CKD patients. As the disease progresses, the incidence of cardiovascular disease in CKD patients gradually increases, especially in End-Stage Renal Disease (ESRD) patients receiving dialysis treatment, where the prevalence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 5, Dialysis, Heart Failure
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jul 2026
- How long will I take part?
- 12 Months
- 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: This study will enroll at least 136 patients meeting inclusion and exclusion criteria who are either currently undergoing maintenance dialysis or newly diagnosed with uremia and scheduled to start maintenance dialysis from July to December 2024 in the Nephrology Department of Shenzhen Second People's Hospital. The study will follow these patients for at least 12 months. During this period, the KCCQ scores and relevant test indicators will be collected regularly to explore the relationship between the baseline KCCQ scores and changes in scores and the occurrence of long-term cardiovascular events and all-cause mortality.
Who may be able to join
- Age 18 or older with no restrictions on gender or ethnicity;
- All enrolled patients meet the diagnostic criteria for CKD stage 5 according to the KDOQI guidelines of the National Kidney Foundation;
- Newly diagnosed uremia patients planning to start maintenance dialysis (hemodialysis or peritoneal dialysis), as well as patients currently undergoing maintenance dialysis treatment (hemodialysis or peritoneal dialysis);
- Clear contact information is available to reach patients or family members for follow-up;
- Signed informed consent and ability to complete the KCCQ.
Who cannot join
- Patients with acute kidney injury from various causes;
- Patients with severe mental illnesses that affect their ability to complete questionnaires;
- Patients who have had acute myocardial infarction, coronary artery stent implantation, coronary artery bypass grafting (CABG) or pacemaker implantation within the past three months;
- Patients with special types of heart disease, including cardiac amyloidosis, congenital heart disease and pericardial diseases;
- Patients with chronic lung diseases;
- Patients with serious underlying conditions such as severe infections, tumors or severe liver diseases;
- Patients scheduled for kidney transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Shenzhen
Guangdong, Guangdong, 518000
Yi Xu, +8613798309505, xuyi20001234@163.com
About this study
Official title: A Prospective Study on Predicting Cardiovascular Events and Mortality Risk in Maintenance Dialysis Patients Based on Changes in KCCQ Scores
Cardiovascular Disease (CVD) is the main complication and the most important cause of death in CKD patients. As the disease progresses, the incidence of cardiovascular disease in CKD patients gradually increases, especially in End-Stage Renal Disease (ESRD) patients receiving dialysis treatment, where the prevalence of cardiovascular disease reaches its highest level. Currently, there is a lack of a simple and reliable tool to assess the cardiac function status and predict the risk of cardiovascular events in patients on maintenance dialysis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a widely used patient-reported outcomes measurement tool for assessing health-related quality of life in heart failure patients. It has been shown that KCCQ scores not only reflect the underlying undiagnosed symptoms of heart failure in CKD patients, but also have a strong correlation with prognosis. However, there is currently insufficient clinical evidence to confirm the value of the KCCQ in patients on maintenance dialysis.
Investigators will perform a prospective, single-center, observational study to collect the changing trend of KCCQ scores at baseline and during the observation periods in maintenance dialysis patients, to analyze the association between the scores and the occurrence of long-term cardiovascular events and all-cause mortality. The aim is to construct a predictive model of KCCQ scores to provide a reference basis for clinical management of this high-risk group, so as to optimize the diagnosis and treatment of heart failure in dialysis patients and improve their cardiovascular outcomes.
Read the detailed description
Investigators will apply the KCCQ to maintenance dialysis patients and statistically analyze baseline KCCQ scores and changing trends to investigate whether they are associated with the occurrence of long-term cardiovascular events and all-cause mortality in dialysis patients and to construct a predictive model associated with KCCQ scores. Patients who meet the inclusion and exclusion criteria will sign an informed consent form, and the baseline index test and the KCCQ assessment will be performed within one week after enrollment. Then the follow-up will be conducted according to the follow-up plan (KCCQ scores and test indexes will be collected at 0, 1, 2, 3, 6, 9 and 12 months in patients with new-onset uremia and the patients with maintenance dialysis will be collected at 0, 3, 6, 9 and 12 months). Conduct a KCCQ assessment and collect relevant indicators during each follow-up visit. There is no intervention in the patient's treatment regimen during the study period. All participants enrolled in the study will be followed up for at least 12 months.
- Conditions
- Chronic Kidney Disease Stage 5, Dialysis, Heart Failure
- Keywords
- Chronic Kidney Disease Stage 5, Maintenance Dialysis, Heart Failure, Cardiovascular Outcomes, Kansas City Cardiomyopathy Questionnaire, patient self-reported outcomes
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality is defined as death from any cause during the study period. This primary outcome measure will assess the occurrence of death among study participants, regardless of the specific cause.
Measured: 12 months
Mortality from cardiovascular causes
Mortality from cardiovascular causes includes deaths resulting from conditions such as myocardial infarction, heart failure, stroke and other cardiovascular event. This primary outcome measure will assess deaths specifically attributed to cardiovascular causes among study participants.
Measured: 12 months
Incidence of cardiovascular disease-related hospitalizations
Cardiovascular disease-related hospitalizations include admissions for conditions such as acute coronary syndrome, heart failure exacerbation, stroke, arrhythmias and other cardiovascular events requiring inpatient care. The primary outcome measure will assess the occurrence of hospitalizations related to cardiovascular diseases among study participants.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jul 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 136 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Xu, Shenzhen Second People's Hospital
- Investigators
- QiJun Wan, Study director, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542016
- Sponsor's protocol ID
- 20240625123
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 7 Aug 2024
- 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Predicting Cardiovascular Events and Mortality Risk in Maintenance Dialysis Patients Based on Changes in KCCQ Scores
- ClinicalTrials.gov ID
- NCT06542016
- Acronym / sponsor ID
- 20240625123
- Conditions
- Chronic Kidney Disease Stage 5, Dialysis, Heart Failure
- Keywords
- Chronic Kidney Disease Stage 5, Maintenance Dialysis, Heart Failure, Cardiovascular Outcomes, Kansas City Cardiomyopathy Questionnaire, patient self-reported outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 7 Aug 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.
Cardiovascular Disease (CVD) is the main complication and the most important cause of death in CKD patients. As the disease progresses, the incidence of cardiovascular disease in CKD patients gradually increases, especially in End-Stage Renal Disease (ESRD) patients receiving dialysis treatment, where the prevalence of cardiovascular disease reaches its highest level. Currently, there is a lack of a simple and reliable tool to assess the cardiac function status and predict the risk of cardiovascular events in patients on maintenance dialysis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a widely used patient-reported outcomes measurement tool for assessing health-related quality of life in heart failure patients. It has been shown that KCCQ scores not only reflect the underlying undiagnosed symptoms of heart failure in CKD patients, but also have a strong correlation with prognosis. However, there is currently insufficient clinical evidence to confirm the value of the KCCQ in patients on maintenance dialysis.
Investigators will perform a prospective, single-center, observational study to collect the changing trend of KCCQ scores at baseline and during the observation periods in maintenance dialysis patients, to analyze the association between the scores and the occurrence of long-term cardiovascular events and all-cause mortality. The aim is to construct a predictive model of KCCQ scores to provide a reference basis for clinical management of this high-risk group, so as to optimize the diagnosis and treatment of heart failure in dialysis patients and improve their cardiovascular outcomes.
Detailed description
Investigators will apply the KCCQ to maintenance dialysis patients and statistically analyze baseline KCCQ scores and changing trends to investigate whether they are associated with the occurrence of long-term cardiovascular events and all-cause mortality in dialysis patients and to construct a predictive model associated with KCCQ scores. Patients who meet the inclusion and exclusion criteria will sign an informed consent form, and the baseline index test and the KCCQ assessment will be performed within one week after enrollment. Then the follow-up will be conducted according to the follow-up plan (KCCQ scores and test indexes will be collected at 0, 1, 2, 3, 6, 9 and 12 months in patients with new-onset uremia and the patients with maintenance dialysis will be collected at 0, 3, 6, 9 and 12 months). Conduct a KCCQ assessment and collect relevant indicators during each follow-up visit. There is no intervention in the patient's treatment regimen during the study period. All participants enrolled in the study will be followed up for at least 12 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll at least 136 patients meeting inclusion and exclusion criteria who are either currently undergoing maintenance dialysis or newly diagnosed with uremia and scheduled to start maintenance dialysis from July to December 2024 in the Nephrology Department of Shenzhen Second People's Hospital. The study will follow these patients for at least 12 months. During this period, the KCCQ scores and relevant test indicators will be collected regularly to explore the relationship between the baseline KCCQ scores and changes in scores and the occurrence of long-term cardiovascular events and all-cause mortality.
Key inclusion criteria (5 listed)
- Age 18 or older with no restrictions on gender or ethnicity;
- All enrolled patients meet the diagnostic criteria for CKD stage 5 according to the KDOQI guidelines of the National Kidney Foundation;
- Newly diagnosed uremia patients planning to start maintenance dialysis (hemodialysis or peritoneal dialysis), as well as patients currently undergoing maintenance dialysis treatment (hemodialysis or peritoneal dialysis);
- Clear contact information is available to reach patients or family members for follow-up;
- Signed informed consent and ability to complete the KCCQ.
Key exclusion criteria (7 listed)
- Patients with acute kidney injury from various causes;
- Patients with severe mental illnesses that affect their ability to complete questionnaires;
- Patients who have had acute myocardial infarction, coronary artery stent implantation, coronary artery bypass grafting (CABG) or pacemaker implantation within the past three months;
- Patients with special types of heart disease, including cardiac amyloidosis, congenital heart disease and pericardial diseases;
- Patients with chronic lung diseases;
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
All-cause mortality
Time frame: 12 months
All-cause mortality is defined as death from any cause during the study period. This primary outcome measure will assess the occurrence of death among study participants, regardless of the specific cause.
Mortality from cardiovascular causes
Time frame: 12 months
Mortality from cardiovascular causes includes deaths resulting from conditions such as myocardial infarction, heart failure, stroke and other cardiovascular event. This primary outcome measure will assess deaths specifically attributed to cardiovascular causes among study participants.
Incidence of cardiovascular disease-related hospitalizations
Time frame: 12 months
Cardiovascular disease-related hospitalizations include admissions for conditions such as acute coronary syndrome, heart failure exacerbation, stroke, arrhythmias and other cardiovascular events requiring inpatient care. The primary outcome measure will assess the occurrence of hospitalizations related to cardiovascular diseases among study participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.
QiJun Wan study director
Shenzhen Second People's 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 Chronic Kidney Disease Stage 5 and Dialysis, run by Shenzhen Second People's Hospital 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 5 inclusion and 7 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 7 Aug 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?
Contact Yi Xu (+8613798309505, xuyi20001234@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 12 months). The study lists 3 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 7 Aug 2024.