A clinical trial evaluating the efficacy of Patiromer in optimizing the therapy with mineralocorticoid receptor antagonists in heart failure patients who also suffer from hyperkalaemia
- Conditions
- Heart Failure with reduced ejection fraction (HFrEF) subjects with hyperkalaemiaMedDRA version: 20.1 Level: PT Classification code 10020646 Term: Hyperkalaemia System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2017-003555-35-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
1. Subjects with HFrEF and left ventricular ejection fraction (LVEF) < 40%
2. New York Heart Association (NYHA) class II or III
3. N/A
4. Male and female adults with age = 18 years
5. Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at Visit S1 (urine) and Visit S2 (serum). Subject must agree to use a highly effective method of birth control during the study and for 1 month after the last dose of study medication.
6. Subjects with hyperkalaemia (serum K+ = 5.1 mmol/L) that limits ability to maintain or to increase eplerenone or spironolactone dose
7. Subjects on MRA therapy in accordance with the respective product label
8. Subjects on stable guideline recommended HF therapy, i.e., on one or more HF therapies (e.g., angiotensin-converting enzyme inhibitor [ACEi], angiotensin receptor blocker [ARB], angiotensin receptor neprilysin inhibitor [ARNi], beta blocker [BB], diuretic) that are anticipated to remain stable during study participation with the exception of the diuretic
9. Subject has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed including screening procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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 < 12 months life expectancy
9. N/A
10. Sustained, as judged by the Investigator, systolic blood pressure (SBP) > 170 or < 90 mmHg
11. Liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of patiromer in optimising MRA therapy in hyperkalaemic HFrEF subjects. ;<br> Secondary Objective: Secondary objectives according to protocol:<br> 1. To assess clinically relevant outcome of optimised MRA therapy in HFrEF subjects<br> 2. To generate initial (pilot) evidence to support potential future trial design<br> Additional objective according to protocol:<br> 3. To evaluate the safety of patiromer in hyperkalaemic HFrEF subjects<br> ;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 Outcome Measures
Name Time Method <br> Secondary end point(s): Secondary endpoints according to protocol:<br> 1) Patient global assessment (PGA)<br> 2) Change in Quality of Life (QoL) European Quality of Life five dimensions questionnaire-five level (EQ-5D-5L)<br> 3) Change in NYHA class and functional capacity<br> 4) Change in eplerenone or spironolactone dosage from baseline over time<br> ;<br> Timepoint(s) of evaluation of this end point: 1), 2) , 3): Day 21 +/- 3 days (Visit 6) and Day 42 +/- 7 days (Visit 8)<br><br> 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)<br>