Multicentre Non-interventional Study of Treatment Outcome in Heart Failure Patients with Hyperkalaemia under RAASi-treatment Receiving Veltassa in Routine Practice

• Conditions: E87.5; Hyperkalaemia

• Registration Number: DRKS00014825
• Lead Sponsor: Vifor Pharma Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-07
• Study Completion: 2020-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. 18 years or older
2. signed informed consent
3. heart failure with left ventricular ejection fraction less than 40%
4. with or without chronic renal insufficiency
5. therapy with inhibitors of the renin-angiotensin-aldosterone-system (RAASi)
6. hyperkalemia (serum potassium values equal/higher than 5.1 mmol/L at baseline that limits ability to maintain or increase the dose of RAASi
7. scheduled for treatment with Veltassa as per label

Exclusion Criteria

1. current dialysis or anticipated during study participation
2. type I diabetes mellitus
3. acute kidney injury
4. cancer with less than 12 months life expectancy
5. heart or kidney transplantation or anticipated during study participation
6. investigational medication currently, 21 days or 5 half-lives prior to baseline
7. inability to consume Veltassa
8. severe medical condition currently or in the last 21 days prior baseline which could decrease study compliance or jeopardize the safety of the patient.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Proportion of patients maintaining or achieving the guideline-recommended (current ESC Guidelines) and evidence-based RAASi target dose at least once during the observation.