Heart Failure with reduced ejection fraction (HFrEF) subjects with hyperkalaemia MedDRA version: 20.1 Level: PT Classification code 10020646 Term: Hyperkalaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Veltassa
Product Name: Patiromer
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Patiromer
CAS Number:
Sponsors
Fresenius Medical Care Nephrologica Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with HFrEF and left ventricular ejection fraction (LVEF) =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery 2. Uncorrected haemodynamically significant primary valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or haemodynamically unstable arrhythmia 3. Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3 months prior to baseline or anticipated need during study participation 4. Heart transplant recipient, or anticipated need for transplant during study participation 5. Any of the following events having occurred within 3 months prior to baseline: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke 6. Current dialysis subject, or anticipated need for dialysis during study participation 7. Prior kidney transplant, or anticipated need for transplant during study participation 8. Cancer with 170 or 5 times upper limit of normal (ULN) 12. Subjects with hypercalcaemia, as judged by the Investigator 13. Use of intravenous (IV) cardiac medications for treatment of decompensated HF within 21 days prior to baseline, or their anticipated need during study participation 14. Use of potassium sparing medication or potassium supplements in the last 7 days prior to baseline 15. Subject is taking any prohibited medication(s) within 7 days prior to baseline or anticipated to be needed during study participation 16. Subject has known hypersensitivity to the active substance of the study product, rare hereditary problems of fructose intolerance or an intolerance to xanthan gum 17. Subject has previously entered this study or another patiromer study 18. Subject is currently enrolled in or has completed any other investigational device or drug study < 21 days or 5 half-lives (whichever is greater) prior to screening, or is receiving other investigational agent(s) 19. Subject has a history of drug or alcohol abuse within 2 years prior to screening 20. Subject has a significant medical condition(s), anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the subject, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator’s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of patiromer in optimising MRA therapy in hyperkalaemic HFrEF subjects. ; Secondary Objective: Secondary objectives according to protocol: 1. To assess clinically relevant outcome of optimised MRA therapy in HFrEF subjects 2. To generate initial (pilot) evidence to support potential future trial design Additional objective according to protocol: 3. To evaluate the safety of patiromer in hyperkalaemic HFrEF subjects ;Primary end point(s): Proportion of subjects maintaining or achieving the guideline-recommended [Ponikowski, 2016] and evidence-based target dose of 50 mg/day eplerenone or spironolactone (see section 7.6) in the patiromer group versus the SoC group at Visit D42.;Timepoint(s) of evaluation of this end point: Day 42 +/- 7 days (Visit 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints according to protocol: 1) Patient global assessment (PGA) 2) Change in Quality of Life (QoL) European Quality of Life five dimensions questionnaire-five level (EQ-5D-5L) 3) Change in NYHA class and functional capacity 4) Change in eplerenone or spironolactone dosage from baseline over time ; Timepoint(s) of evaluation of this end point: 1), 2) , 3): Day 21 +/- 3 days (Visit 6) and Day 42 +/- 7 days (Visit 8) 4) : At each visit from Visit 3 (Day 3 +/- 1 day) unto Visit 9 (follow-up visit taking place 7 - 14 days after Visit 8) | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
Winicker Norimed GmbH Medizinische Forschung
Outcome results
None listed