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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 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Xu | Contact | +8613798309505 | xuyi20001234@163.com | |
| Jiafang Li | Contact | +8618685742697 | 18685742697@139.com |
| Name | Affiliation | Role |
|---|---|---|
| QiJun Wan | Shenzhen Second People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Shenzhen | Recruiting | Guangdong | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |