Withdrawal of Pharmacological Treatment in Patients Responding to Cardiac Resynchronization Therapy: (REMOVE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Relapse of cardiomyopathy at any time during the study after drug withdrawal, defined by at least one of the following: 1. A reduction in LVEF of more than 10% (as long as the overall LVEF is < 50%). 2. A reduction in LVEF of more than 10% accompanied by a >15% increase in left ventricular end-systolic volume. 3. Unplanned hospital admission or visit to the Emergency Department/day hospital due to decompensated HF requiring the administration of intravenous diuretics.
研究概览
简要总结
To determine the effect of withdrawing pharmacologic treatment in patients with cardiac resynchronization therapy with recovered LVEF, in terms of both imaging parameters (changes in LVEF and LV volume) as well as clinical parameters that reflect worsening of the heart failure.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who have received cardiac resynchronization therapy at least one year before for left bundle branch block and LVEF <40% of non-ischemic origin.
- •Current LVEF ≥ 50% and normal volumes in two studies consecutive echocardiograms, separated by at least 3 months, with the last performed in the previous six months.
- •NYHA functional class I-II
- •Absence of admissions for heart failure in the last year
- •NT-proBNP <450 pg/mL in patients in sinus rhythm or <900 pg/mL in patients with atrial fibrillation, in the previous 6 months.
- •Pharmacological treatment with beta-blockers, ACEIs/ARA II/ARNI with or without ARM
- •Normally functioning cardiac resynchronization therapy device with >95% pacing
- •Older than 18 years
- •Patients who have given their written informed consent.
排除标准
- •Previous episode of sustained ventricular tachycardia/sudden death recovered/appropriate discharge (in case of being a carrier of implantable cardioverter-defibrillator associated with cardiac resynchronization therapy)
- •Uncontrolled arterial hypertension (figures >140/90 mmHg).
- •Need for the use of beta-blockers at the medical discretion of 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.
- •Diabetics or hypertensives with microalbuminuria or proteinuria
- •Renal failure with creatinine clearance < 30 ml/min/1.73m
- •Fertile women who do not use contraception or are sterilizedsurgically; pregnant or lactating women.
- •Currently participating in a clinical trial or have participated in the previous 30 days
结局指标
主要结局
Relapse of cardiomyopathy at any time during the study after drug withdrawal, defined by at least one of the following: 1. A reduction in LVEF of more than 10% (as long as the overall LVEF is < 50%). 2. A reduction in LVEF of more than 10% accompanied by a >15% increase in left ventricular end-systolic volume. 3. Unplanned hospital admission or visit to the Emergency Department/day hospital due to decompensated HF requiring the administration of intravenous diuretics.
Relapse of cardiomyopathy at any time during the study after drug withdrawal, defined by at least one of the following: 1. A reduction in LVEF of more than 10% (as long as the overall LVEF is < 50%). 2. A reduction in LVEF of more than 10% accompanied by a >15% increase in left ventricular end-systolic volume. 3. Unplanned hospital admission or visit to the Emergency Department/day hospital due to decompensated HF requiring the administration of intravenous diuretics.
次要结局
- Combined total mortality, cardiovascular mortality, hospital admission or visit to the Emergency Department/unplanned day hospital for HF, and sustained atrial or ventricular arrhythmias (>30 seconds).
- Changes with respect to the basal levels of BP and HR.
- Change from baseline in LVEF, LVTVV, left atrial volume indexed by body surface area (VAIi), and changes from baseline in left ventricular (LV) longitudinal global strain (LSG).
- Quantitative changes in NT-proBNP numbers.
- Changes in the quality of life questionnaires according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living With Heart Failure (MLHFQ) scale.
研究者
Maria
Scientific
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia