EUCTR2018-004882-15-DE进行中（未招募）1 期
Effect of angiotensin receptor neprilysin inhibitor sacubitril/valsartan on cardiopulmonary exercise tolerance in patients with hypertrophic cardiomyopathy – a randomized controlled clinical Phase II trial (EntREG – SILICOFCM) - EntREG-SILICOFCM
niversity Hospital Regensburg0 个研究点目标入组 40 人开始时间: 2019年3月21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
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1)Adults =18 years of age
- •2)Confirmed diagnosis of hypertrophic cardiomyopathy
- •3)Agreement to be a participant in the study protocol and willing/able to return for follow-up
- •4)Able to provide written informed consent
- •5)In women of childbearing age: Willingness to use a highly effective contraceptive method (failure rate per year < 1%)
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1)Less than 3 months post septal reduction therapy (surgery or catheter-based intervention)
- •2)Clinical cardiac decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms.
- •3)Resting blood pressure > 180/100 mm Hg or systolic blood pressure < 100 mmHg
- •4)Hypotensive response to exercise testing (=20 mmHg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure =20 mmHg).
- •5)Concomitant use of angiotensin converting inhibitors or angiotensin receptor blockers; patients previously receiving angiotensin-converting enzyme inhibitor or angiotensin receptor blocker therapy will require a 36-hour washout period before initiation of ARNI (Sacubitril/Valsartan)
- •6)Resting left ventricular outflow tract gradient > 50 mmHg.
- •7)Left ventricular ejection fraction < 50% by echocardiography.
- •8)Implanted pacemaker or cardio-defibrillator in the last 3 months or scheduled.
- •9)History of hyperkalaemia (serum potassium >5.2 mmol/l).
- •10)Renal insufficiency with a glomerular filtration rate < 30 mL/min per 1.73m2.
- •11)Present or planned pregnancy.
- •12)Life expectancy less than 12 months.
- •13)Patients with severe adipositas (adipositas permagna, body mass index >40 kg/m2).
- •14)History of exercise induced syncope or sustained ventricular arrhythmias.
- •15)Inability to exercise due to orthopaedic or other non-cardiovascular limitations.
- •16)Use of other investigational drugs at the time of enrolment.
- •17)Concomitant treatment with aliskiren-containing drugs; discontinuation of treatment with aliskiren-containing drugs is required before initiation of ARNI (Sacubitril/Valsartan)
- •18)History of angiotensin converting inhibitors- or angiotensin receptor blockers-induced angioedema or history of hereditary or idiopathic angioedema.
- •19)Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2x ULN, severe hepatic insuffucuency (classification Child Pugh C), biliary cirrhosis, cholestasis (current or anamnesic evidence), history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
- •20)Any surgical or medical condition that in the opinion of the investigator may place the patient at higher risk from his/her participation in the study or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •21)History of noncompliance to medical regimens and patients who are considered potentially unreliable.
- •22)History or evidence of drug or alcohol abuse within the past 12 months.
- •23)History of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin or localized prostate cancer), treated or untreated, within the past 2 years, regardless of whether there is evidence of local recurrence or metastases.
- •24)Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and AF or atrial flutter with a resting ventricular rate >110 beats per minute.
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