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临床试验/DRKS00011133
DRKS00011133已完成4 期

Impact of right heart function and pulmonary venous Hypertension on CRT Response in patients with left ventricular dysfunction and dyssynchrony - Bivent

niversitätsklinikum Magdeburg0 个研究点目标入组 115 人开始时间: 2017年1月30日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
115

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • 1. Patients with heart failure symptoms lasting at least 6 weeks (according to the
  • current guidelines for CRT treatment of chronic heart failure)
  • 2. At least 18 years of age
  • 3. Medical need for implants (implants based on the standard implant guidelines
  • from the European Society of Cardiology (ESC))
  • 4. Left ventricular ejection fraction (LVEF) < 35% as assessed by the investigator
  • 5. NYHA functional status II, III or IV
  • 6. QRS duration > 130 ms
  • 7. Medical therapy, unless contraindicated, includes
  • - ACE inhibitor or
  • - AT1 blocker given for at least one month before enrolment,
  • - Beta-blocker started at least 3 months before enrolment,
  • - aldosterone antagonist
  • Dosage of therapies mentioned above must be unchanged for at least one month.
  • 8. The patient must have given its written informed consent to participate in the
  • study after receiving adequate previous information and prior to any study
  • specific procedures.

排除标准

  • 1. Life expectancy < 12 months
  • 2. Pregnancy (routine test before left and right heart catheter examination)
  • 3. Prior CRT
  • 4. Atrial arrhythmias
  • 5. Right bundle branch block
  • 6. QRS < 130 ms
  • 7. Heart failure requiring continuous intravenous therapy
  • 8. Patients with acute coronary syndromes or coronary revascularization within 4
  • months before CRT

研究者

发起方
niversitätsklinikum Magdeburg

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