Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy. (DRUGLESS-CRT)
Withdrawal of Heart Failure Treatment in Patients With Non-ischemic Cardiomyopathy, Without Late Gadolinium Enhancement and With a Negative Genetic Test, Who Have Been Super-responders to Cardiac Resynchronization Therapy.
Multicenter, prospective, non-inferiority, randomized, single-blind (primary endpoint evaluators blinded, patients not blinded) clinical trial.
We aim to evaluate if the withdrawal of heart failure treatment is safe in patients with non-ischemic cardiomyopathy, negative genetic test, no evidence of late gadolinium enhancement on cardiac MRI, who have been super-responders to cardiac resynchronization therapy and remain free of heart failure events for at least 6 months after device implantation.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Andrea Di Marco, MD, PhD
- 电话号码：+34932607686
- 邮箱：adimarco@bellvitgehospital.cat
学习地点
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-
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Barcelona、西班牙
- 招聘中
- Hospital Vall d'Hebron
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接触：
- Jaume Francisco Pascual
- 电话号码：+34932607686
- 邮箱：adimarco@bellvitgehospital.cat
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Girona、西班牙
- 招聘中
- Hospital Trueta
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接触：
- Carles Moliner
- 电话号码：+34932607686
- 邮箱：adimarco@bellvitgehospital.cat
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Granada、西班牙
- 招聘中
- Hospital Virgen de las Nieves
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接触：
- Laura Jordan
- 电话号码：+34932607686
- 邮箱：adimarco@bellvitgehospital.cat
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、西班牙、08907
- 招聘中
- Hospital Universitari de Bellvitge
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接触：
- Andrea Di Marco
- 电话号码：+34932607686
- 邮箱：adimarco@bellvitgehospital.cat
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of non-ischemic cardiomyopathy
- LBBB already present at the time of first diagnosis of LV dysfunction
- Negative genetic test
- Cardiac MRI with no evidence of late gadolinium enhancement (LGE at RV insertion points is acceptable)
- Carrier of a resynchronization device (ICD or pacemaker, with LV epicardial pacing form a cardiac vein or left bundle area pacing), pacing percentage >95% and paced QRS <140 ms
- Device indication: LVEF ≤35% and LBBB with QRS >150 ms
- LVEF ≥50% and normal indexed LV volumes on echocardiogram performed at least 6 months after CRT implantation
- No heart failure decompensations (no hospitalizations or urgent/day hospital visits) since CRT implantation
- No need for loop diuretic treatment
- NYHA class I or II
- NT-proBNP <450 ng/L (or <1000 ng/L in atrial fibrillation/flutter)
- On neurohormonal therapy with at least two drugs
Exclusion Criteria:
- Family history of non-ischemic cardiomyopathy with LVEF <50% in at least one first-degree relative
- Severe valvular heart disease
- History of sustained ventricular arrhythmia or treated by ICD
- Need to maintain beta-blocker therapy for other arrhythmias
- Hypertension not controlled with other medications
- CRT devices implanted as an upgrade from prior pacemaker or ICD, where prior pacing percentage was >20%
- Clinical indication other than heart failure to maintain any of the neurohormonal treatment drugs (class I recommendation in ESC or ACC/AHA guidelines)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control Group
Continue heart failure medical tretment without changes |
|
|
有源比较器：Drugs withdrawal group
Heart failure medications are progressively withdrawn, in a máximum period of 9 weeks, always with the same protocol in every patient. |
Heart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months
大体时间：6 months
|
Any of the following events:
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Emergency room or day hospital visits for heart failure
大体时间：6 and 12 months
|
6 and 12 months
|
|
|
Hospitalizations due to heart failure
大体时间：6 and 12 months
|
6 and 12 months
|
|
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Ventricular arrhythmias
大体时间：6 and 12 months
|
Sustained ventricular tachycardia, sudden cardiac death, appropriate ICD therapy |
6 and 12 months
|
|
Supraventricular arrhythmias
大体时间：6 and 12 months
|
Sustained supraventricular arrhythmia, including sustained atrial fibrillation, sustained atrial flutter and sustained atrial tachycardia |
6 and 12 months
|
|
NYHA class
大体时间：6 and 12 months
|
New York Heart Association functional class, limits I-IV, higher scores means worse outcome |
6 and 12 months
|
|
NtproBNP
大体时间：6 and 12 months
|
levels of NTproBNP, as measured in blood sample |
6 and 12 months
|
|
Quality of life, assessed with KCCQ
大体时间：6 and 12 months
|
KCCQ: Kansas City Cardiomyopathy Questionnaire, minimum and maximum values 0-100, higher scores indicate better outcome |
6 and 12 months
|
|
Quality of life as evaluated with the EQ-5D-5L, EQ VAS
大体时间：6 months and 12 months
|
EuroQol five-dimension, five-level questionnaire - visual analogue scale, minimum and maximum value 0-100, higher score indicates better outcome |
6 months and 12 months
|
|
Quality of life evaluated with the EQ-5D-5L-index value
大体时间：6 months and 12 months
|
EuroQol five-dimension, five-level questionnaire - index value, minimum and maximum value 0-1, higher score indicates better outcome |
6 months and 12 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- DRUGLESS-CRT
- 2025 (美国 NIH 拨款/合同)
- 2025-521780-12-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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