EUCTR2017-003555-35-DE进行中（未招募）1 期
A Multicentre, Randomised, Open-label, Parallel-Group Pilot Study to Evaluate the Efficacy of Patiromer in Optimising Mineralocorticoid Receptor Antagonist Therapy in Heart Failure Subjects with Hyperkalaemia - CONTINUE-HF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subjects with HFrEF and left ventricular ejection fraction (LVEF) < 40%
- •2. New York Heart Association (NYHA) class II or III
- •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
排除标准
- •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
- •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
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