E87.5
Conditions
Interventions
Group 1: Patients with chronic heart failure with a left ventricular ejection fraction of less than 40% with or without CKD (Chronic Kidney Disease) who receive inhibitors of the renin-angiotensin-ald
Sponsors
Vifor Pharma Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. RAASi therapy compared to baseline, over time and at end of study. The Proportion of patients on same or higher RAASi dose and receiving target dose according to the current ESC guidelines, the change of RAASi dose and the maximum dose achieved. The change in serum potassium level from baseline over time and the proportion of patients with serum potassium level equal/higher than 5.1 to less than 5.5, equal/higher than 5.5 to less than 6.0 and equal/higher than 6.0 mmol/L, overall and over time. 2. Veltassa therapy during observation time (duration, mean dose, dose changes and interruptions, discontinuation). 3. Change in NYHA class 4. Kidney function and HF parameters (change and proportion of patients where kidney function and HF parameters have been measured and where these parameters were elevated or decreased, overall and over time). 5. Change in Patient reported outcomes. 6. Investigator´s satisfaction with Veltassa therapy. 7. The incidence and severity of AEs 8. The proportion of patients with decreased estimated glomerular filtration rate overall and over time. 9. The proportion of patients with elevated blood pressure, overall and over time. 10. Concomitant (non-RAASi) drug use. | — |
Countries
Germany
Contacts
Public ContactKatharina Brünger
Vifor Pharma Deutschland GmbH
Outcome results
None listed