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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,331
Research Site
Huntsville, Alabama, United States
Research Site
La Jolla, California, United States
Research Site
Rancho Cucamonga, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Nampa, Idaho, United States
Research Site
Description of change in HK management decision at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Description of HK management objective(s) decision at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Description of expected HK management duration decision at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Change in time to K+ normalization at 3 month intervals.
Time frame: Up to 12 months following enrolment.
Description of HK recurrence frequency.
Time frame: Up to 12 months following enrolment.
Description of average dose of Renin angiotensin aldosterone system inhibitor (RAASi) therapy.
Time frame: 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.
Time frame: Up to 12 months following enrolment.
Description of occurrences of HK complications such as arrythmia, muscle weakness, and metabolic acidosis.
Time frame: Up to 12 months following enrolment.
Description of Healthcare resource utilization (HCRU).
Time frame: Up to 12 months following enrolment.
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Hinsdale, Illinois, United States
Research Site
Princeton, New Jersey, United States
Research Site
Albany, New York, United States
Research Site
New York, New York, United States
Research Site
Abington, Pennsylvania, United States
...and 64 more locations