Hyperkalemia
Conditions
Keywords
Treatment pathways,, Hyperkalemia,, High level of Serum potassium., Treatment rationale,, Treatment objective,, Treatment expectations,, Heart failure and, Chronic kidney disease.
Brief summary
This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months. The generation of real-world evidence (RWE) to understand the treatment management decision rationale and to prospectively describe patient characteristics, treatment management patterns among patients with HK is of importance to improve adherence to guidelines and improve patient care. The primary objective: • Describe HK management decisions, their rationale and treatment expectations. The secondary objective: • Describe baseline characteristics and longitudinal clinical variables in patients with HK. The exploratory objective: • Describe patient awareness and satisfaction with their HK treatment management across the study period.
Detailed description
This study is a multinational, observational, prospective, longitudinal, cohort study that will include primary and secondary data collection. Secondary data, collected as per routine clinical practice will be extracted from electronic health records (EHR) and manually entered into the electronic case report form (eCRF). Primary data will be collected directly from patients and Health Care Providers (HCPs). Prospective data collection will be performed for a period of 12 months and will include data collection at baseline, that is, the date of enrollment, and at 3-, 6-, 9-, and 12-months following baseline. The data collection timepoints in this study is irrespective of when the patient's medical visits are scheduled. There are no study specific patient visits mandated by protocol and study may be fully virtual.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
Patients meeting all the following inclusion criteria will be eligible for inclusion into the study: 1. Age ≥18 years on the date of signing informed consent 2. HK with serum potassium (K+) level(s) greater than 5.0 mmol/L, collected during Standard of Care, within 21 days prior to the date of enrollment\* 3. Provision of signed and dated informed consent (\*enrollment in study is defined as the date of Informed consent and confirmation of study eligibility, whichever occurs later). Patients will be excluded from the study if they meet any of the following criteria: 1. Concurrent participation in any trial that includes the use of K+ binders as an investigational medicinal product (IMP) 2. Patients with pseudohyperkalemia 3. A life expectancy of less than six months, based on physician judgement 4. Acute causes of HK such as infections and/or trauma to be determined by the principal investigator 5. Scheduled renal transplant 6. Involvement in the planning and/or conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of expected HK management duration decision at 3 month intervals. | Up to 12 months following enrolment. |
| Description of change in HK management decision at 3 month intervals. | Up to 12 months following enrolment. |
| Description of HK management objective(s) decision at 3 month intervals. | Up to 12 months following enrolment. |
Secondary
| Measure | Time frame |
|---|---|
| Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy. | Up to 12 months following enrolment. |
| Change in time to achieve target dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy at 3 month intervals. | Up to 12 months following enrolment. |
| Description of Healthcare resource utilization (HCRU). | Up to 12 months following enrolment. |
| Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis. | Up to 12 months following enrolment. |
| Change in time to K+ normalization at 3 month intervals. | Up to 12 months following enrolment. |
| Description of HK recurrence frequency. | Up to 12 months following enrolment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Description of change in awareness and satisfaction to HK management by patient reported outcome (PRO) at 3 month intervals. | Up to 12 months following enrolment. | Functional Assessment of Chronic Illness Therapy Treatment Satisfaction-General (FACIT-TS-G) and bespoke questions on dietary recommendations. |
Countries
Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed