Prognostic Modeling of Heart Failure Risk in a Large-Scale Asian Cohort With Chronic Kidney Disease: The CKD-Heart Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incident heart failure (HF), Cardiovascular death (CV Death) and All-cause death
研究概览
简要总结
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.
详细描述
1.1 Background and rationale for conducting this study
Patients with chronic kidney disease (CKD), a clinical scenario closely associated with multiple co-morbid conditions (e.g., hypertension, diabetes, and coronary artery diseases), are less likely to receive guideline-directed foundational medical therapy due to clinical concerns about hyperkalemia and hypotension, and are thereby prone to the development of heart failure (HF). In this regard, early identification and prevention of HF is important (1). To date, N-terminal pro-brain natriuretic peptide (NT-pro-BNP) has been shown to be a powerful clinical predictor of HF, though its clinical utilization is easily affected by renal insufficiency, thus limiting its use in these patients (2).
1.2 Rationale for study design, doses and control groups
Overall rationale and study population:
Recent studies have shown improvement in cardiovascular outcomes, particularly in HF, and renal protective effects of SGLT2 inhibitors (3). Early identification of HF among CKD patients in a pre-clinical HF stage may allow appropriate pharmacological interventions as early as possible to reduce future HF burden. Yet, data regarding the exact clinical characteristics and risk stratification for HF diagnosis in CKD subjects that may benefit from interventions remain largely unexplored.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incident heart failure (HF), Cardiovascular death (CV Death) and All-cause death
时间窗: From enrollment to the end of observation for at least 5 years
次要结局
- 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)
研究者
Chung-Lieh Hung
• 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
Mackay Memorial Hospital