Clareo Health | An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with hyperkalemia who meet the following criteria:
1\) 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:
1\) 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
2\) 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
You may not be if
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.
