An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients
Recruiting · NCT06542016 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shenzhen Second People's Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- First Shenzhen - Guangdong, Guangdong, China