EUCTR2018-003662-14-GB进行中（未招募）1 期
Patiromer-facilitated, dose-escalation of mineralocorticoid antagonists for the management of worsening congestion in people with heart failure and hyperkalaemia. A Phase IV, registry-based, randomised, controlled, open-label trial investigating the potential for patiromer-facilitated use of higher doses of mineralocorticoid antagonists in addition to standard care (compared to standard care alone) to improve congestion, well-being, morbidity and mortality. - RELIEHF (RELieving Increasing oEdema due to Heart Failure), v1.0
HS Greater Glasgow and Clyde0 个研究点目标入组 2,000 人开始时间: 2019年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
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
- 性别
- All
入选标准
- •For the Screening Log (no linkage to electronic medical records or follow-up)
- •1. =18 years
- •2. Heart failure in the investigators opinion (new onset or decompensated chronic heart failure)
- •3. Planned to receive >=80mg/day of furosemide or equivalent (IV or oral) in the next 24 hours.
- •4. Worsening symptoms & signs of congestion in the prior 10 days requiring at least one of the following:
- •a) hospitalisation
- •b) administration of intravenous diuretics
- •c) doubling of the dose of loop diuretic (e.g.:- from 40mg to 80mg/day or 80mg to 160mg/day)
- •d) addition of a thiazide diuretic to treatment with a loop diuretic
- •For the Consented Registry (with linkage to electronic medical records)
- •1. Fulfils the criteria for the screening log
- •2. Able and willing to provide written informed consent for registry participation
- •For Randomised Trial Run-in
- •1. Fulfils criteria for the consented registry
- •2. Clinical diagnosis of heart failure for at least 4 weeks
- •3. Congestion as shown by at least one of the following:
- •a) Peripheral oedema
- •b) Raised venous pressure
- •c) Inferior vena cava diameter >20mm
- •4. Cardiac dysfunction documented by at least one of the following in the previous three years:
- •a) Left ventricular ejection fraction <50% or a report of moderate or severe left ventricular dysfunction
- •b) Left atrial diameter >3.0cm/m2 (body surface area)
- •c) Elevated BNP or NT-proBNP
- •(i)BNP >150ng/L if in sinus rhythm or >450ng/L if not in sinus rhythm
- •(ii)NT-proBNP >500ng/L if in sinus rhythm and >1500ng/L if not in sinus rhythm
- •5. Able and willing to provide written informed consent for the randomised trial
- •For Randomisation
- •1. Serum potassium >5.0mmol/L
- •Patients with a serum potassium >5.0mmol/L may be randomised immediately unless they have severe hyperkalaemia requiring, in the investigators opinion, intravenous treatment or a potassium binding agent.
- •Severe hyperkalaemia should be managed according to the UK Renal Association guidelines of 2014 (https://renal.org/wp-content/uploads/2017/06/hyperkalaemia-guideline-1.pdf). Participants may be reconsidered for the trial once such interventions are no longer considered necessary.
- •Patients with a serum potassium =5.0mmol/L should be initiated on spironolactone or have the dose increased up to 100mg/day and randomised only if serum potassium exceeds 5.0mmol/L. Those intolerant of or unwilling to take spironolactone should be offered eplerenone titrated to a maximum dose of 50mg/day.
- •A run-in period of up to 35 days is permitted (the run-in period will usually occur during hospitalisation or a course of day-care or intense management).
- •2. After ingestion of a test-dose of patiromer,
- •the patient is willing to continue in the trial
- •the investigator considers the patient can follow instructions on preparing patiromer.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1300
排除标准
- •For the Screening Log and Consented Registry
- •For the Randomised Trial
- •1. eGFR <30ml/minute/1.73m2 (if clinically appropriate, the dose of other agents such as loop diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers and sacubitril-valsartan may be adjusted to allow eGFR to increase)
- •2. Systolic BP <90mmHg
- •3. Uncorrected valve disease as the main cause of heart failure in the investigators opinion
- •4. Hepatic encephalopathy or known severe liver disease
- •5. Infection currently requiring intravenous antibiotics or temperature >38oC
- •6. Myocardial ischaemia currently requiring intravenous therapy or coronary intervention or coronary intervention in the previous 7 days
- •7. Arrhythmia requiring urgent cardioversion or intravenous therapy
- •8. Severe hyperkalaemia requiring, in the investigator’s opinion, intravenous treatment or a potassium-binding agent
- •9. The patient is already receiving a potassium-binding agent (this includes patiromer) or the treating physician has already decided to use one.
- •10. Known hypersensitivity to patiromer or any of the excipients.
- •11. Known intolerance to spironolactone or eplerenone (not including hyperkalaemia)
- •12. Known hypersensitivity to the active substance or excipients of spironolactone and eplerenone as per the current Summary of Product Characteristics (Note: actual medicine supplied to participants will vary depending on local arrangements)
- •13. Women of child bearing potential. For the purposes of this trial this means any woman aged <60 years unless they have had a hysterectomy or bilateral tubal ligation or are aged >50 years and have undergone the menopause and had amenorrhea for at least 3 years
- •14. Patients taking the following systemic medicines:
- •strong inhibitors of CYP 3A4 (e.g. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
- •Tacrolimus or Cyclosporin
- •15. The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)
- •16. Rare hereditary problems of galactose or fructose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •17. Known amyloid heart disease
- •18. Cancer likely to cause death or major disability within the next three years
- •19. Patients requiring mechanical circulatory support
- •20. Patients who do not develop a serum potassium >5.0mmol/L despite receiving up to 100mg/day of spironolactone or 50mg/day of eplerenone during the run in phase.
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