Overview

This trial is active, not recruiting.

Conditions heart failure, sudden death
Treatment mibg for diagnostic purpose
Sponsor Assistance Publique - Hôpitaux de Paris
Start date September 2010
End date December 2016
Trial size 330 participants
Trial identifier NCT01185756, AOM : 08085

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
MIBG for diagnostic purpose: MIBG scintigraphy for diagnostic purpose
mibg for diagnostic purpose
All patients will undergo the diagnostic test specific to the study.

Primary Outcomes

Measure
Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.
time frame: 1-3 months

Secondary Outcomes

Measure
Sudden cardiac death
time frame: 1-3 months
Overall mortality
time frame: 1-3 months
Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.
time frame: every 6 months during 3 years
sudden cardiac death
time frame: every 6 months during 3 years
Overall mortality
time frame: every 6 months during 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator Dominique Le Guludec, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.