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临床试验/EUCTR2015-005351-27-GB
EUCTR2015-005351-27-GB进行中(未招募)1 期

A randomised controlled pilot trial of the feasibility and safety of therapy withdrawal in asymptomatic patients with a prior diagnosis of dilated cardiomyopathy & recovered cardiac function. - Therapy withdrawal in REcovered Dilated cardiomyopathy trial (TRED)

Royal Brompton & Harefield NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2016年1月19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)
入组人数
50

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

  • 1. Diagnosis of DCM confirmed by 2 independent operators based on clinical details and previous imaging.
  • 2. Currently taking at least 1 of the following medications: loop diuretic, beta blocker, Angiotensin Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB) and Mineralocorticoid Receptor antagonist (MRA).
  • 3. Evidence of Left Ventricular Reverse Remodelling (LVRR) following the initial diagnosis with subsequent improvement in ejection fraction from =40% to =50% and normalisation of LV volumes on CMR (1) (or echocardiography if a contraindication to CMR exists).
  • 4. Without symptoms of heart failure (NYHA Class 1) (2).
  • 5. Plasma NTproBNP <250ng/ml.
  • (1) Maceira et al. Normalized left ventricular systolic and diastolic function by steady state free precession cardiovascular magnetic resonance. JCMR 2006;8:417-426.
  • (2) The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 25
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 25

排除标准

  • 1. Uncontrolled hypertension (clinic blood pressure >160/100mmHg)
  • 2. Age < 16 years
  • 3. More than moderate valvular disease
  • 4. Estimated glomerular filtration rate <30mls/min
  • 5. Atrial/supraventricular/ventricular arrhythmia requiring beta-blockade.
  • 6. Pregnancy
  • 7. Angina.

研究者

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