An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients

NCT06542016 | Recruiting

• 1 other identifier: 20240625123
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

First Shenzhen

Guangdong, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• QiJun Wan

  Shenzhen Second People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Yi Xu

CONTACT

+8613798309505; xuyi20001234@163.com

Jiafang Li

CONTACT

+8618685742697; 18685742697@139.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: July 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CN (1)