NCT05151861Unknown4 期
Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: Open and Randomized Study
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3. Clinical evidence of HF (Heart Failure) based on a global assessment, both clinical and analytical, together with the need to increase the dose of diuretics, as adjudicated by the research team.
研究概览
简要总结
The purpose of this randomized trial is to investigate the effect of the complete removal of pharmacological treatment in patients responding to cardiac resynchronization therapy with recuperated LVEF in terms of imaging parameters (changes in LVEF and LV volume), as well as, clinical parameters that translate into worsening of heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a CRT device for at least one year due to the presence of LBBB and LVEF <40% of non-ischemic origin
- •Current LVEF ≥50% and normal volumes in two consecutive echocardiographic studies, separated at least 3 months, and the last one performed in the previous 6 months.
- •Normally functioning CRT device with stimulation> 95%.
- •NYHA functional class I-II.
- •Absence of admissions for HF in the last year.
- •NT-proBNP <450pg/ml in sinus rhythm and <900pg/ml in patients with atrial fibrillation, in the previous 6 months.
- •Pharmacological treatment with beta-blockers, ACEIs/AIIRA/RNAI with or without MRA.
- •Older than 18 years.
- •Patients who have given their informed consent in writing.
排除标准
- •Previous episode of sustained ventricular tachycardia/recovered sudden death/appropriate shock (in the case of a patient with an implantable cardioverter-defibrillator associated with CRT).
- •Uncontrolled arterial hypertension (figures> 140/90 mmHg).
- •Need to use beta-blockers at the medical discretion for other indications such as heart rate (HR) control in atrial fibrillation (in the absence of ablation of the atrioventricular node) or to control other supra or ventricular arrhythmias.
- •Severe valve disease.
- •Diabetic or hypertensive with microalbuminuria or proteinuria.
- •Renal failure with creatinine clearance <30ml/min/1.73m
- •Fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women.
- •Patients are currently participating in a clinical trial or have participated in the past 30 days.
研究组 & 干预措施
Experimental
Experimental
Complete removal of pharmacological treatment
干预措施: Complete removal of pharmacological treatment (Other)
Control
Active Comparator
Maintenance of pharmacological treatment
干预措施: Control (Drug)
结局指标
主要结局
3. Clinical evidence of HF (Heart Failure) based on a global assessment, both clinical and analytical, together with the need to increase the dose of diuretics, as adjudicated by the research team.
时间窗: Up to 48 weeks
Number of patients with echocardiographic studies
1. A reduction in LVEF (Left ventricular ejection fraction) of more than 10%
时间窗: Up to 48 weeks
Number of patients with echocardiographic studies
2. An increase >15% in the VTSVIi (The end-systolic volume of the indexed left ventricle) to the previous one and in a range higher than the normal value
时间窗: Up to 48 weeks
Number of patients with echocardiographic studies
次要结局
- Cardiovascular mortality,(Up to 48 weeks)
- Unplanned hospital admission or emergency room visit for HF (Heart Failure)(Up to 48 weeks)
- total mortality, (Number )(Up to 48 weeks)
- Changes with respect to baseline levels of BP (Blood pressure )(Up to 48 weeks)
- Changes with respect to baseline levels of HR figures. (heart rate)(Up to 48 weeks)
- Change from baseline LVEF(Up to 48 weeks)
- Change from baseline left ventricular end-diastolic volume (VTDVIi)(Up to 48 weeks)
- Unplanned hospital admission or emergency room visit for sustained atrial or ventricular arrhythmias (>30 seconds).(Up to 48 weeks)
- Changes from baseline in global longitudinal strain (GLS).GLS is a simple parameter that expresses longitudinal shortening as a percentage (change in length as a proportion to baseline length).(Up to 48 weeks)
- Changes in the quality of life questionnaires according to The Minnesota Living with Heart Failure (MLHFQ) scales.(Up to 48 weeks)
- Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) scales.(Up to 48 weeks)
- Change from baseline body surface indexed left atrium volume (VAIi)(Up to 48 weeks)
研究者
研究点 (1)
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