JPRN-jRCTs021210046招募中4 期
Program of Angiotensin-Neprilysin Inhibition in Admitted Patients with Worsening Heart Failure - PREMIER study
ode Koichi0 个研究点目标入组 400 人开始时间: 2021年11月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients must provide written informed consent themselves to participate in this study
- •2)Aged 20 or older at consent (male or female)
- •3)Hospitalized due to worsening heart failure with both signs of congestion (such as edema, moist rales, and congestion on chest X-ray) and symptoms of heart failure (such as dyspnea on mild exertion or at rest) (any level of left ventricular ejection fraction)
- •4)NYHA class II-IV
- •5)Taking an ACE inhibitor or an ARB
- •6)Can undergo randomization within 7 days of current hospitalization
- •7)Patients who meet the following criteria of hemodynamic stability
- •I.Systolic blood pressure >100 mm Hg
- •II.No dose increase of intravenous diuretic within 6 hours before randomization
- •III.No intravenous administration of vasodilator (such as carperitide or nitrates) or positive inotropic agent
- •8)Patients who meet the following reference range for natriuretic peptide level from 48 hours before current hospitalization to the time of eligibility determination
- •NT-proBNP >-1200 pg/mL or BNP >-300 pg/m
排除标准
- •1)Currently taking oral sacubitril valsartan or have taken it within 30 days prior to randomization
- •2)History of hypersensitivity to ingredients in ARB, ACE inhibitor, or sacubitril valsartan; or expected to be contraindicated for or intolerant to any of these drugs
- •3)History of angioedema
- •4)Severe renal dysfunction (5)Severe liver dysfunction (Child-Pugh class C)
- •6)Diabetic patients who are currently taking aliskiren fumarate
- •7)Serum potassium >5.3 mEq/L or more
- •8)Cardiogenic shock
- •9)On cardiopulmonary support, with a left ventricular assist device, or on a ventilator
- •10)Onset of stroke or acute coronary syndrome within 30 days prior to randomization
- •11)History of surgical or percutaneous treatment of cardiovascular disease within 30 days prior to randomization
- •12)Patients with an advanced plan for surgical or percutaneous treatment of cardiovascular disease or for coronary artery revascularization during an observation period
- •13)Patients with an advanced plan for pacemaker implantation, cardiac resynchronization therapy, or electrical cardioversion during an observation period
- •14)History or comorbidity of hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy such as amyloidosis or sarcoidosis
- •15)Active pericardial disease
- •16)History of or awaiting heart transplant
- •17)Severe chronic respiratory disease or active infectious disease
- •18)Patients who are or might become pregnant or who are breastfeeding
- •19)Patients whom a study investigator determined to be unsuitable for the study (such as patients with comorbid active malignancy)
研究者
相似试验
进行中（未招募）
1 期
Influences of Sacubitril/Valsartan (ENTRESTO®) on centrally generated sympathetic activity in heart failure patientsChronic heart failure with reduced left ventricular ejection fraction (NYHA II-III)MedDRA version: 20.0Level: LLTClassification code 10078289Term: Heart failure with reduced ejection fractionSystem Organ Class: 100000004849EUCTR2017-000394-36-DEHannover Medical School35
招募中
不适用
Angiotensin receptor-neprilysin inhibitor in patients with acute myocardial infarction and heart failureAcute myocardial infarctionJPRN-UMIN000046004Chiba University Hospital1,000
已完成
不适用
The effect of blood pressure medicines in Coronary Artery operatioCardiovascular disease.Atherosclerotic heart diseaseIRCT2013100514862N1Vice Deputy Ahvaz Jundishapur University of Medical Sciences54
进行中（未招募）
1 期
Angiotensin-neprilysin blockage after myocardial infarctioDiastolic dysfunction after acute myocardial infarctionMedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849EUCTR2017-002020-25-DKOdense University Hospital100
进行中（未招募）
1 期
Effect of the drug sacubitril/valsartan on physical performance in patients with hypertrophic cardiomyopathyhypertrophic cardiomyopathyEUCTR2018-004882-15-DEniversity Hospital Regensburg40