CKD-Heart: Heart Failure Prediction in Asian CKD Patients

NCT06677489 | Active Not Recruiting DMC

• 1 other identifier: 23MMHIS240e
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Among patients with known chronic kidney disease (CKD) who are free from diagnosed heart failure (HF), some may be classified as stage A-B HF based on the contemporary 2022 ACC/AHA Guideline for Heart Failure Classification. Several key clinical features and risk factors have been shown to serve as predictors for future HF development. Importantly, compared to white populations, Asians may present with distinct HF risks even when exhibiting the same conventional clinical risk factors for CKD. Our current study aimed to explore the clinical predictors of HF and adverse cardiovascular events among CKD patients in a pre-clinical HF stage (Stage A-B) within a large ethnic Asian population. We further investigated whether baseline characteristics from echocardiography, ECG, and urine protein measurements could provide additional prognostic insights on future events. Addressing this knowledge gap for such a population may facilitate early identification and timely interventions for CKD patients of Asian ethnicity in the early stages of the disease.

Conditions

Chronic Kidney Disease(CKD)

Keywords

cardiovascular disease; biomarkers; chronic kidney disease; heart failure; echocardiogram

Outcome Measures

Primary Outcomes (1)

• Incident heart failure (HF), Cardiovascular death (CV Death) and All-cause death

  From enrollment to the end of observation for at least 5 years

Secondary Outcomes (1)

• 1. Non-fatal cardiovascular events or CV Death (MACE), Atrial fibrillation (AF)/Atrial flutter (AFL) related hospitalization; 2. Echocardiography defined structural and functional abnormalities.

  From enrollment to the end of observation for at least 5 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study group: Retrospective study: Pooled data from 9000-10000 CKD patients at Mackay Memorial Hospital Data collection range: retrospective data collection from 2011 to 2020

You may qualify if:

• Clinical diagnosis of CKD (an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m², persisting for 3 months or more)
• Age ≥ 20 years
• Free at baseline of diagnosed HF
• Baseline patient-level clinical data available

You may not qualify if:

• Known HF hospitalization history
• Known impaired LV systolic function (LVEF\<40%) by any imaging modality
• Any terminal disease other than CKD lowering the patient's life expectancy to less than two years
• eGFR ≥ 60ml/min/1.73m2

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

MacKay Memorial Hospital

Taipei, Taiwan, 104217, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases; 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: • Director of Ultrasound Imaging and Telemedicine, Cardiovascular Center, Mackay Memorial Hospital • Director of the Department of Heart Failure and Imaging Medicine, Cardiovascular Center, Mackay Memorial Hospital

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: August 21, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)