NCT05297409已完成不适用
Hyperkalemia Registry An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Patient characteristics including socio-demographic variables, severity of disease and comorbidities
研究概览
简要总结
This prospective observational research will be conducted to assess the burden of hyperkalemia including treatment and disease burden of patients in a long-term continuous care from various aspects including adherence to the medication for hyperkalemia and HR-QoLs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with hyperkalemia who meet the following criteria:
- •Being treated with potassium binders for hyperkalemia at the time of enrolment, and having started receiving potassium binders within 6 months before enrolment
- •Having been diagnosed as CKD (≥stage 3b) or HF diagnosed by investigators, and as defined below:
- •CKD is diagnosed based on the CKD guidelines issued by the Japanese Society of Nephrologyxxix as being either or both of condition 1 and 2 for ≥3 months
- •1-i) Clear signs of kidney impairment based on the results of urinalysis, imaging, blood test, or biopsy. Presence of proteinuria, especially more than 0.15 g/gCr (albuminuria more than 30 mg/gCr).
- •1-ii) GFR <45 mL/min/1.73m2
- •Patients with HFwill be enrolled if patients meet following criteria: 2-i) NYHA class II-IV, within 6 months 2-ii) Patients with a diagnosis or history of heart failure, hospitalization, and laboratory records of any of the following; NT-proBNP≥400 pg/ml or BNP≥100 pg/ml, or pathological findings such as abnormal cardiac function by UCG/CT/MRI/catheterization/nuclear medicine examination
- •Provision of signed, written, and detailed informed consent
排除标准
- •Currently on any chronic RRT (including hemodialysis or peritoneal dialysis >30 days, or kidney transplant) within 6 months before enrolment
- •Patients with acute kidney injury (AKI)* within 6 months before enrolment
- •Patients with acute heart failure within 3 months before enrolment
- •Patients who received blood transfusion within 6 months before enrolment
- •Patients with active malignancy or whose life expectancy is less than 6 months
- •GI disturbance, chronic diarrhoea, or GI stoma if, as judged by the investigators, that condition or its treatment has an important impact on S-K values
- •Autoimmune disease if, as judged by the investigators, that condition or its treatment has an important impact on S-K values
- •Patients who are suspected, on the basis of laboratory data, to have pseudohyperkalemia (abnormality in the sample, a history of severe leukocytopenia or thrombocytopenia)
- •Patients with recent traumatic injury
- •Patients who are pregnant, lactating, or planning to become pregnant
- •Current participation in a clinical trials, i.e. an interventional studies
- •Presence of a condition that, in the opinion of the investigator, i) would places the subject at undue risk, or ii) would potentially jeopardizes the quality of the data to be generated, or iii) would prevent the patient from performing protocol-defined tasks for physical or mental reasons, or iv) would prevent the patient from understanding the contents of the self-administered questionnaire and responding to its questions on his/her own, or v) would, for some other reason, make the patient inappropriate for this study.
结局指标
主要结局
Patient characteristics including socio-demographic variables, severity of disease and comorbidities
时间窗: 6 month
Health-Related Quality of Life
时间窗: 6 month
Serum Potassium
时间窗: 6 month
次要结局
- Nutritional status(6 month)
- Use of healthcare resource(6 month)
- Status of metabolic acidosis(6 month)
研究者
研究点 (1)
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