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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01185756
Other study ID # AOM : 08085
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 9, 2010
Last updated January 10, 2018
Start date September 2010
Est. completion date January 2018

Study information

Verified date December 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 330
Est. completion date January 2018
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
MIBG for diagnostic purpose
All patients will undergo the diagnostic test specific to the study.

Locations

Country Name City State
France Groupe Hospitalier Bichat - Claude Bernard Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias. Description appropriate therapy delivered by the ICD, or sustained ventricular tachycardia. 1-3 months
Secondary Sudden cardiac death 1-3 months
Secondary Overall mortality 1-3 months
Secondary Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias. description appropriate therapy delivered by the ICD or sustained ventricular tachycardia every 6 months during 3 years
Secondary sudden cardiac death every 6 months during 3 years
Secondary Overall mortality every 6 months during 2 years
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