An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients Wi… (NCT05297409) | Clinical Trial Compass
CompletedNot Applicable
An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
Japan352 participantsStarted 2022-05-21
Plain-language summary
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.
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 bef…
What they're measuring
1
Patient characteristics including socio-demographic variables, severity of disease and comorbidities