Advanced Heart Failure: The Predictive Value of Dobutamine Echo-stress in the Clinical Response to Cardiac Contractility Modulation Therapy (CCM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 13
- 主要终点
- New York Heart Association class variation
研究概览
简要总结
The goal of this observational cohort study, which is both retrospective and prospective, is to evaluate the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) treatment in adult subjects suffering from symptomatic heart failure (HF) due to systolic left ventricular dysfunction, despite adequate medical therapy. Based on the response to stress echocardiography with preimplantation low-dose Dobutamine, the main questions it aims to answer are:
- What is the proportion of subjects who experience a clinical response to CCM therapy at 12 months (NYHA reduction ≥ 1 class)?
- There was a reduction in the number of hospitalizations, visits to the Emergency Department, and access to day hospital facilities for more than 4 hours compared to the year before the study (e.g., by intravenous infusion of cardiac inotropic drugs)?
- What is the estimated change in the quality-of-life score using the "Quality of Life Questionnaire with Heart Failure - Minnesota" (MLHFQ) between baseline and the end of follow-up?
- What is the change in walking distance between baseline and the end of the follow-up in the walk test (6MWT) (optional)?
- What is the difference in NT-proBNP levels between baseline and the end of follow-up? Participants are already receiving CCM support as part of their regular medical care for heart failure.
详细描述
-Introductory summary When no other therapeutic options are available, CCM can be a helpful complement to treating heart failure, improving quality of life, and prolonging survival. Still, the high cost and availability of implants in qualified centers limit their use.
Then, searching for indicators that maximize the benefit/risk ratio is appropriate. According to the study's proponents, the contractile reserve of the left ventricle assessed by stress echo to low-dose Dobutamine may be among the most promising indicators for this purpose.
Introduction Heart failure (H.F.) has a very poor prognosis in terms of mortality, quality of life, and functional capacity. It is one of the most important cardiovascular diseases in terms of global prevalence and healthcare costs. Despite appropriate medical care, many patients experience frequent hospitalizations and limitations in daily activities (1).
The prevalence of heart failure ranges between 1% and 3% in the general adult population in industrialized countries. It is expected to increase substantially due to the availability of better diagnostic tools and medical treatments that prolong life after diagnosis of HF (2).
The latest international guidelines on the management of reduced ejection fraction H.F. recommend a timely approach with the simultaneous introduction of the four main categories of drugs (ACE inhibitors or ARNIs, beta-blockers, mineralocorticoid receptor antagonists (MRAs), and SGLT2 inhibitors). If drug therapy alone is not sufficient or not well tolerated by the subject, or if there is a disorder in the conduction of the electrical impulse (in particular, a left bundle branch block), it is possible to associate it with electrical therapy, which consists of the implantation of biventricular cardiac devices (pacemakers or defibrillators) that resynchronize cardiac contraction (cardiac resynchronization therapy, CRT). These devices work in close synergy with anti-decompensation drugs to curb the progression of heart failure and, in some cases, restore normal cardiac contractility. Cardiac resynchronization therapy, combined with drug therapy, has been shown to improve survival and quality of life by reducing the symptoms of heart failure, increasing exercise capacity, and enabling subjects to resume many of their daily activities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Subject of both sexes with age ≥ 18 years,
- •Ability to understand and sign informed consent to participate in the study and consent to process sensitive personal data.
- •Carrier of symptomatic heart failure, despite optimal medical therapy (OMT),
- •Reduced left ventricular systolic function (E.F. <50%),
- •It was positively evaluated for implanting a system for cardiac contractility modulation (CCM) (according to the European Society of Cardiology 2021 Guidelines on heart failure and the provisions of the C.E. mark approval)
- •Have presented at least one hospitalization, access to the Emergency Department, or access to day hospital facilities for more than 4 hours (e.g., by intravenous infusion of cardiac inotropic drugs) in the year before implantation
排除标准
- •Life expectancy < 1 year due to non-cardiac comorbidities that reduce prognosis,
- •Presence of contraindications to the CCM implantation procedure (absence of vascular access usable for CCM implantation, active infectious processes, active severe coagulopathies, presence of mechanical tricuspid valve),
- •Contraindications to the performance of the echocardiographic test under pharmacological stress (heart failure in progress, myocardial infarction in the acute phase, acute inflammatory processes of the heart muscle and/or pericardium, critical aortic valve stenosis and severe obstructions to left ventricular outflow, dissecting aneurysm of the aorta, severe arrhythmias not controlled by therapy, known hypersensitivity to the drug, intraventricular thrombi).
结局指标
主要结局
New York Heart Association class variation
时间窗: From enrollment to the end of follow-up, 12 months
The proportion of subjects with clinical response to CCM therapy at 12 months, defined as a reduction of at least 1 class of the New York Heart Association Classification of the functional status of the heart (minimum value I, better outcome, and maximum value IV, worse outcome)
次要结局
- Hospitalizations(From enrollment to the end of follow-up, 12 months)
- Minnesota LIVING WITH HEART FAILURE Questionnaire score variation(From enrollment to the end of follow-up, 12 months)
- 6MWT variation(From enrollment to the end of follow-up, 12 months)
- NT-proBNP variation(From enrollment to the end of follow-up, 12 months)
- LVESV change(From enrollment to the end of follow-up, 12 months)
- VTI change(From enrollment to the end of follow-up, 12 months)
- LVEF change(From enrollment to the end of follow-up, 12 months)
- MR change(From enrollment to the end of follow-up, 12 months)
- CRT implant(From enrollment to the end of follow-up, 12 months)
- LVAD implant(From enrollment to the end of follow-up, 12 months)
- Cardiac Transplant(From enrollment to the end of follow-up, 12 months)
- HF death(From enrollment to the end of follow-up, 12 months)
- AE(From enrollment to the end of follow-up, 12 months)
- Re-Operation(From enrollment to the end of follow-up, 12 months)