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)
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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