Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)

Официальное название

Using Cardiovascular Magnetic Resonance Identified Fibrosis to Assess Sudden Cardiac Death Risk in Patients With Non-ischemic Dilated Cardiomyopathy and the Unknown Therapeutic Risk Reduction of Contemporary Heart Failure Medication and Implantable Cardioverter-Defibrillators

Обзор

Research questions: The value of primary prevention implantable cardioverter-defibrillator implantation (ICD) therapy in patients with non-ischemic cardiomyopathy (NICM) is under debate. Improved risk stratification is needed to select patients at highest risk. Hypotheses: 1. In NICM patients with CMR detected myocardial fibrosis, ICD implantation reduces all-cause mortality compared to guideline-directed medical therapy (GDMT) only. 2. Myocardial fibrosis assessed by cardiac MRI (CMR) can be used to stratify patients according to risk for sudden cardiac death. Study design: 1. Patients with myocardial fibrosis: Randomized controlled trial (RCT). 2. Patients without myocardial fibrosis: Prospective registry. Study population: Patients with non-ischemic cardiomyopathy with LVEF \<35% after at least 3 months of guideline-directed medical therapy (GDMT). Intervention: ICD implantation. Main study parameters/endpoints: primary endpoint: all-cause mortality. Secondary endpoints include: patient clinical status, quality of life, sudden cardiac death, ventricular arrhythmias, ICD complications and ICD therapy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All ICDs that are implanted in the study are standard devices that are used in daily clinical practice. Patients who are randomized to ICD implantation will be subjected to the risk of perioperative and long-term complications but will be partly protected against death from ventricular arrhythmias. Patients randomized to no ICD implantation will not be protected against the residual risk of sudden cardiac death but are not subjected to complications from ICD implantation and possible subsequent complications. The only additional burden for patients is completing quality-of-life questionnaires, all hospital visits are for routine follow-up.

Вмешательства

• Устройство ICD implantation
  implantation of a non-resynchronisation ICD

Первичные конечные точки

• all-cause mortality [Срок оценки: 36 months]

Вторичные конечные точки (5)

• sudden cardiac death [Срок оценки: 36 months]
• quality of life as measured by standardized questionnaires [Срок оценки: 36 months]
• ventricular arhythmias [Срок оценки: 36 months]
• ICD-related complications [Срок оценки: 36 months]
• ICD therapy [Срок оценки: 36 months]

Критерии участия

Критерии включения

• Non-ischemic cardiomyopathy
• Left ventricular late gadolinium enhancement on MRI, but not hinge-point fibrosis
• Left ventricular ejection fraction <35% on any modality
• Functional class NYHA I-III
• At least 3 months optimal medical treatment for heart failure

Критерии исключения

• Indication for cardiac resynchronization therapy
• Functional class NYHA IV
• Typical ischemic scar tissue on CMR
• Amyloidosis, sarcoidosis, hypertrophic cardiomyopathy, complex congenital heart disease
• high-risk mutations causing DCM
• Patient on waiting list for heart transplantation
• Left ventricular assist device present
• Severe valve disease
• Secondary prevention indication for ICD
• Untreated cardiac ischemia
• High competing risk of death (>35% in 1 year according to HFmetascore)
• Active chemotherapy for cancer
• Severe renal failure with dialysis expected within 3 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• University Medical Center Groningen — Groningen
• Radboud University Medical Center — Nijmegen

Идентификаторы

NCT: NCT07415642 · DUTCH-ICD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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