Evaluating heart risk in dialysis patients using the KCCQ score
A Prospective Study on Predicting Cardiovascular Events and Mortality Risk in Maintenance Dialysis Patients Based on Changes in KCCQ Scores
This study is trying to see if the Kansas City Cardiomyopathy Questionnaire scores can help predict heart risks in people with chronic kidney disease who are on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shenzhen Second People's Hospital Academic / other |
| Locations | 1 site (Guangdong, Guangdong) |
| Trial ID | NCT06542016 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in patients undergoing maintenance dialysis for chronic kidney disease stage 5. Investigators will analyze baseline KCCQ scores and their changes over time to determine their association with long-term cardiovascular events and all-cause mortality. The study will involve regular follow-ups over a 12-month period to collect KCCQ assessments and relevant health indicators without altering patients' treatment regimens. The goal is to develop a predictive model for cardiovascular risk based on KCCQ scores.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with chronic kidney disease stage 5 who are either newly diagnosed and planning to start maintenance dialysis or currently undergoing maintenance dialysis.
Not a fit: Patients with acute kidney injury, severe mental illnesses affecting questionnaire completion, or recent significant cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for predicting cardiovascular risk in dialysis patients, potentially improving patient management and outcomes.
How similar studies have performed: While the KCCQ has been used in heart failure populations, this specific application in dialysis patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangdong, Guangdong
- First Shenzhen — Guangdong, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yi Xu
- Email: xuyi20001234@163.com
- Phone: +8613798309505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.