Clinical trial NCT06542016: An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients
Official title: A Prospective Study on Predicting Cardiovascular Events and Mortality Risk in Maintenance Dialysis Patients Based on Changes in KCCQ Scores
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older with no restrictions on gender or ethnicity;
2. All enrolled patients meet the diagnostic criteria for CKD stage 5 according to the KDOQI guidelines of the National Kidney Foundation;
3. 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);
4. Clear contact information is available to reach patients or family members for follow-up;
5. Signed informed consent and ability to complete the KCCQ.

Exclusion Criteria:

1. Patients with acute kidney injury from various causes;
2. Patients with severe mental illnesses that affect their ability to complete questionnaires;
3. Patients who have had acute myocardial infarction, coronary artery stent implantation, coronary artery bypass grafting (CABG) or pacemaker implantation within the past three months;
4. Patients with special types of heart disease, including cardiac amyloidosis, congenital heart disease and pericardial diseases;
5. Patients with chronic lung diseases;
6. Patients with serious underlying conditions such as severe infections, tumors or severe liver diseases;
7. Patients scheduled for kidney transplantation.

Primary outcomes:
measure: All-cause mortality
timeFrame: 12 months
measure: Mortality from cardiovascular causes
timeFrame: 12 months
measure: Incidence of cardiovascular disease-related hospitalizations
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangdong
country: China
facility: First Shenzhen
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: QiJun Wan
role: STUDY_DIRECTOR
References: