EUCTR2019-004862-16-DE进行中（未招募）1 期
A Phase 2, Multicentre, Double-Blind, Placebo and Active Control Efficacyand Safety Study to Evaluate Verinurad combined with Allopurinol in HeartFailure with Preserved Ejection Fraction - AMETHYST
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
- 150
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
- •- Patient must be = 40 years of age at the time of signing the ICF
- •- Patients with hyperuricaemia defined as sUA level of > 6 mg/dL.
- •- Patients with documented diagnosis of symptomatic HFpEF according to all of the
- •following criteria:
- •(a) Have NYHA functional class II-III at enrolment
- •(b) Have medical history of typical symptoms/signs of HF > 6 weeks before enrolment
- •(c) LVEF = 45%
- •(d) NT-proBNP = 125 pg/mL (= 14.75 pmol/L) at Visit 2 for patients without ongoing
- •atrial fibrillation/flutter.
- •- Patients able to exercise to near exhaustion during a CPET as exhibited by RER
- •= 1.05 during CPET conducted during screening. If patient does not achieve RER = 1.05 the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before
- •randomisation) after the initial test; in such cases the second test will serve as baseline.
- •- Male or female
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •- eGFR < 30ml/min/1.73m2 (based on CKD-EPI formula)
- •- Severe hepatic impairment (Child-Pugh class C)
- •- Presence of any condition that precludes exercise testing
- •- Known history of a documented LVEF < 40%
- •- Probable alternative or concomitant diagnoses which in the opinion of the Investigator
- •could account for the patient's HF symptoms and signs (eg, anaemia, hypothyroidism)
- •- Known carrier of the Human Leukocyte Antigen-B (HLA-B) *58:01 allele: HLA-B
- •*58:01 genotyping is mandatory prior to randomization for all patients.
- •- Patients diagnosed with tumor lysis syndrome or Lesch-Nyhan syndrome
- •- Patients who are severely physically or mentally incapacitated and who in the opinion of
- •investigator are unable to perform the patients’ tasks associated with the protocol
- •- Presence of any condition which, in the opinion of the investigator, places the patient at
- •undue risk or potentially jeopardises the quality of the data to be generated
- •- Current acute decompensated HF or hospitalisation due to decompensated HF < 4 weeks
- •prior to enrolment
- •- Myocardial infarction, unstable angina, coronary revascularisation (percutaneous
- •coronary intervention or coronary artery bypass grafting), ablation of atrial
- •flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronisation
- •therapy device, stroke or transient ischemic attack within 6 months prior to enrolment.
- •- Planned coronary revascularisation, ablation of atrial flutter/fibrillation and/or valve
- •repair/replacement
- •- Atrial fibrillation with persistent resting heart rate > 110 beats per minute.
研究者
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