Actively Recruiting
A Prospective Study on Predicting Cardiovascular Events and Mortality Risk in Maintenance Dialysis Patients Using Changes in KCCQ Scores
Led by Shenzhen Second People's Hospital · Updated on 2024-08-07
136
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiovascular disease is the leading complication and cause of death for patients with chronic kidney disease (CKD), especially those with End-Stage Renal Disease (ESRD) undergoing dialysis. This research aims to evaluate the Kansas City Cardiomyopathy Questionnaire (KCCQ), a tool that measures patient-reported heart failure symptoms, to see if changes in KCCQ scores can predict long-term cardiovascular events and overall mortality in dialysis patients. The study seeks to build a predictive model to help improve diagnosis and treatment of heart failure in this high-risk group. This is a prospective, single-center observational study involving patients on maintenance dialysis or newly diagnosed with uremia starting dialysis. There is no change to patients' treatments during the study. KCCQ assessments and relevant clinical tests will be collected at enrollment and then regularly during follow-up visits over 12 months. New uremia patients will have KCCQ scores collected at 0, 1, 2, 3, 6, 9, and 12 months, while maintenance dialysis patients will be assessed at 0, 3, 6, 9, and 12 months. Participants will complete the KCCQ questionnaire and undergo clinical evaluations at each visit. Researchers will track all-cause mortality, deaths from cardiovascular causes, and hospitalizations related to cardiovascular disease over 12 months. The study involves no interventions and aims to observe natural changes in health status. Follow-up will be at least one year to monitor outcomes and collect data for the predictive model.
CONDITIONS
Brief Title
An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older with no gender or ethnicity restrictions
- Diagnosed with chronic kidney disease stage 5 according to KDOQI guidelines
- Newly diagnosed uremia patients planning to start maintenance dialysis or patients currently on maintenance dialysis
- Clear contact information available for follow-up
- Signed informed consent and ability to complete the KCCQ questionnaire
You will not qualify if you...
- Acute kidney injury from any cause
- Severe mental illness affecting ability to complete questionnaires
- Acute myocardial infarction, coronary stent implantation, coronary artery bypass grafting, or pacemaker implantation within the past 3 months
- Special heart diseases such as cardiac amyloidosis, congenital heart disease, or pericardial diseases
- Chronic lung diseases
- Serious conditions like severe infections, tumors, or severe liver diseases
- Scheduled for kidney transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants complete baseline KCCQ assessments and relevant test indexes within one week after enrollment.
1 baseline visit (in-person or remote)
Duration - At least 12 months
Participants are followed for at least 12 months with repeated KCCQ assessments and collection of relevant indicators to observe cardiovascular events and mortality risk. New-onset uremia patients have assessments at 0, 1, 2, 3, 6, 9, and 12 months; maintenance dialysis patients have assessments at 0, 3, 6, 9, and 12 months.
Multiple visits depending on cohort: new-onset uremia patients have up to 7 visits; maintenance dialysis patients have up to 5 visits
Trial Site Locations
Total: 1 location
1
First Shenzhen
Guangdong, Guangdong, China, 518000
Actively Recruiting
Research Team
Y
Yi Xu
J
Jiafang Li
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here