Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542016
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Study on Predicting Cardiovascular Events and Mortality Risk in Maintenance Dialysis Patients Based on Changes in KCCQ Scores
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 patients treatment regimen during the study period All participants enrolled in the study will be followed up for at least 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None