Clinical trial NCT01185756: MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)
Official title: Can we Better Select Patients With Heart Failure for a Primary Prevention Indication of Implantable Cardioverter Defibrillator (ICD)? Evaluation of the Diagnostic Value of 123I Meta-iodobenzylguanidine (MIBG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Sudden Death
Keywords: Heart failure
Sudden death
Implantable Cardioverter Defibrillator
MIBG scintigraphy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator. Cardiac innervation will be assessed using an imaging agent administered intravenously.

Detailed description: The survival benefit provided by implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death in heart failure compared to medical treatment alone is well established. First limited to the most severe patients, the indications have gradually been extended in accordance with the results of more recent studies. This beneficial effect in terms of public health is accompanied by an increase in health spending which threatens to grow strongly at short and medium term. However, the majority of ICDs implanted will not be solicited because of the overall low incidence of severe ventricular arrhythmias in the population meeting the implantation criteria. To optimize our resources, it is therefore important to better assess the risk of sudden death in those patients candidates for ICD implantation.

The overactivation of NEURO-humoral systems plays an important role in the progression of heart failure, and in the occurrence of ventricular arrhythmias. The iodine-123 meta-iodobenzylguanidine scintigraphy (MIBG), is a functional imaging method that can noninvasively evaluate cardiac sympathetic innervation. It has been shown that cardiac adrenergic hyperactivation estimated by MIBG scintigraphy was associated with a poor outcome, and that its value was independent and superior to other prognostic factors in heart failure. More importantly, the risk of occurrence of major cardiac events is minimal when the cardiac uptake of MIBG is high. Furthermore, plasma natriuretic peptides (particularly BNP and NT-proBNP), which are other indicators of the NEURO-hormonal activation used in the diagnosis and assessment of prognosis in heart failure, are predictive of the risk of occurrence of sudden death in the same population. In summary, the MIBG scintigraphy and NT-proBNP are two prognostic markers in heart failure related to the degree of NEURO-hormonal dysfunction, and have a good negative predictive value of mortality. Their combined use could therefore help identify patients at low risk of severe arrhythmias.These tests are not currently part of heart failure diagnosis in patients who are candidates for ICD implantation.

Eligibility criteria: Inclusion Criteria:

* Indication for ICD in primary prevention according to European Society of Cardiology guidelines

Exclusion Criteria:

* Secondary prevention indication of ICD
* Acute coronary syndrome within the last 40 days
* Revascularization procedure (bypass or percutaneous coronary angioplasty) performed within the last 3 months of planned
* Pregnancy or lactating female

Primary outcomes:
measure: Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.
timeFrame: 1-3 months
Secondary outcomes:
measure: Sudden cardiac death
timeFrame: 1-3 months
measure: Overall mortality
timeFrame: 1-3 months
measure: Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.
timeFrame: every 6 months during 3 years
measure: sudden cardiac death
timeFrame: every 6 months during 3 years
measure: Overall mortality
timeFrame: every 6 months during 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Bichat - Claude Bernard
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique Le Guludec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: