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临床试验/NL-OMON47257
NL-OMON47257已完成2 期

Ventricular tachyarrhythmia detection by Implantable Loop Recording in Patients with Heart Failure and Preserved Ejection Fraction - VIP-HF Registry

niversitair Medisch Centrum Groningen0 个研究点目标入组 250 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Clinical criteria:
  • 1. Age >18 years
  • 2. Written informed consent
  • 3. HF with moderate to severe symptoms NYHA II or III
  • 4. Hospitalization or emergency room visit for HF or symptom relief with diuretics within 12 months
  • 5. Sinus rhythm or AF with adequate rate control (exercise test: maximum heart rate <160 bpm) ;Echocardiographic criteria:
  • 1. LVEF >40%
  • 2. Left atrial size (volume *34 mL/m2 or LA parasternal diameter *45 or left ventricular hypertrophy (septal thickness or posterior wall thickness *11 mm) of left ventricular diastolic dysfunction (E/e* *13 or mean e* septal and lateral wall <9 cm/s).;Biomarker criteria:
  • 1. BNP >75ng/L or NT-pro-BNP>300ng/L if sinus rhythm
  • 2. BNP >225ng/L or NT-pro-BNP>900ng/L if atrial fibrillation

排除标准

  • 1. Patients unwilling or unable to sign informed consent
  • 2. Patients with a pacemaker or ICD
  • 3. Indication for ICD therapy according to the European Society of Cardiology (ESC) guidelines
  • 4. Life expectancy of less than one year
  • 5. Significant coronary artery disease or myocardial infarction < 3 months
  • 6. Complex congenital heart disease
  • 7. Pregnancy

研究者

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