CRT-P or CRT-D in Patients With Dilated Cardiomyopathy and Heart Failure Without LGE-CMR High-risk Markers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 924
- 试验地点
- 2
- 主要终点
- Major adverse cardiac events (MACE)
研究概览
简要总结
The ICD-Reality study is a non-commercial, investigator-led, multicenter, prospective, randomized, controlled trial. We aim to determine the effect of CRT-D or CRT-P implantation in non-ischemic cardiomyopathy and heart failure patients.
The reason why we initiated this trial is the lack of evidence-based treatment for the significant number of these patients. In these patients, 5-year mortality remains as high as 20% despite recent therapeutic advances. Based on currently available evidence, because of a significant decrease in mortality due to modern pharmacotherapy, it is not certain which of these patients should receive a CRT-P and who should receive a CRT-D. No dedicated and adequately powered trial has addressed this important question.
We hypothesize that patients with symptomatic HF, LVEF ≤35%, without left ventricular mid-wall fibrosis on LGE-CMR, will not benefit from CRT-D implantation compared with CRT-P only implantation.
If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures.
We aim to enroll 600 patients in the trial. 924 patients are needed to be screened for these 600 patients to be randomized.
Patients with non-ischemic HF visiting an out-patient department and possibly eligible for the trial will have their pharmacotherapy optimized.
Patients with a significant amount of fibrosis will be excluded from the study and treated according to local practice with an emphasis on ICD implantation to prevent SCD.
After fulfilling all eligibility criteria, including maximally tolerated pharmacotherapy, subjects will be randomized by the physicians who enrolled them in a 1:1 ratio to receive CRT-D or CRT-P implantation.
All patients will be followed-up for at least 3 years after the implantation.
详细描述
The trial goals The ICD-Reality study is an investigator-led, multicenter, prospective, randomized, controlled trial. We aim to determine the effect of CRT-D or CRT-P implantation in non-ischemic cardiomyopathy and heart failure patients. The reason why we initiated this trial is the lack of evidence-based treatment for the significant number of these patients. In these patients, 5-year mortality remains as high as 20% despite recent therapeutic advances. Based on currently available evidence, because of a significant decrease in mortality due to modern pharmacotherapy, it is not certain which of these patients should receive an ICD. We hypothesize that patients with symptomatic HF, LVEF ≤35%, without left ventricular mid-wall fibrosis on LGE-CMR, will not benefit from CRT-D implantation compared with CRT-P only implantation. If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures.
Clinical hypothesis:
Patients with symptomatic HF, with LVEF ≤35% and without LV mid-wall fibrosis on late gadolinium enhancement cardiovascular magnetic resonance imaging (CMR), will not benefit from CRT-D implantation compared with CRT-P only implantation.
Estimated number of patients needed to be screened and randomized:
600 patients are needed to be randomized according to the study power analysis. Since 35 % of patients are estimated to be LG-E positive and thus excluded from randomization, 924 patients are needed to be screened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Trial participants will be blinded to the device type for the whole duration of the trial.
The randomizing and implanting physicians will not be blinded to the type of the device. These physicians will not take care in the subsequent patients' follow-up and sign a declaration of confidentiality.
The same will be true for the physicians / technicians attending to the device interrogation during follow-up visits. The device type will be hidden and physicians will sign a declaration of confidentiality. The patients' documentation will not reveal the device type.
A maximum effort will be done to hide the type of the implanted device. The implantation will be intramuscular and the device interrogation follow-up visits will not reveal the device type.
The physicians attending the follow-up visits and entering all patients' data into web-based CRF will be blinded to the implanted device type.
The outcomes assessors will also be blinded to the implanted device type.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age at the time of screening
- •Documented non-ischemic HF with an LVEF ≤ 35
- •QRS≥130ms; NYHA class II-IV
- •Signed written informed consent
- •NT-proBNP above 200 pg/ml
排除标准
- •Uncorrected congenital heart disease or valve obstruction
- •obstructive cardiomyopathy
- •active myocarditis
- •constrictive pericarditis
- •untreated hypothyroidism or hyperthyroidism
- •adrenal insufficiency
- •active vasculitis due to collagen vascular disease
- •Presence on the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent)
- •Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study
- •Recipient of any major organ transplant (e.g., lung, liver, heart)
- •Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomization or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of > 2.5 years in the opinion of the investigator)
- •Known to be human immunodeficiency virus positive with an expected survival of less than 5 years due to HIV
- •Chronic kidney disease with glomerular filtration rate <30 ml/min
- •Chronic dialysis treatment
- •Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report
- •Any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
- •Unwilling to participate
- •Additional information related to inclusion and exclusion criteria:
- •The qualifying LVEF and NT-proBNP level has to be measured after a maximal tolerated pharmacotherapy of heart failure has been achieved.
- •A non-ischemic cause of HF has to be determined by coronary angiography. Patients could be included even if they will have one or two coronary arteries with stenosis, if the extent of coronary artery disease will not be considered to be sufficient to account for the reduced LVEF. Patients with a significant coronary heart disease (CAD) will be excluded.
- •Patients with an existing conventional pacemaker could be included if they will be willing to have the device changed or upgraded.
- •Patients with any form of atrial fibrillation will not be excluded.
研究组 & 干预措施
CRT-D
Implantation of cardiac resynchronization therapy with a defibrillator (CRT-D)
干预措施: CRT-D (Device)
CRT-P
Implantation of cardiac resynchronization therapy pacemaker (CRT-P)
干预措施: CRT-P (Device)
结局指标
主要结局
Major adverse cardiac events (MACE)
时间窗: 0-3 years after device implantation
Event rate of MACE, defined as a composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Re-hospitalization for heart failure
时间窗: 0-3 years after device implantation
Event rate
Ventricular tachycardia
时间窗: 0-3 years after device implantation
Event rate, sustained ventricular tachycardia documentation during follow-up
次要结局
- Sudden cardiac death(0-3 years after device implantation)
- Cardiovascular death(0-3 years after device implantation)
- Resuscitated cardiac arrest or sustained ventricular tachycardia(0-3 years after device implantation)
- Device-related complications(0-3 years after device implantation)
- The impact in terms of overall quality of life by the SF-36 Questionnaire(3 years after device implantation)
- The impact in terms of overall quality of life by the MacNew Questionnaire(3 years after device implantation)
研究者
Tomas Skala, MD, PhD, FESC
Principal investigator
University Hospital Olomouc