MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)

Heart Failure Clinical Trial

— MISTIC  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01185756
• Other study ID #: AOM : 08085
• 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
• 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

Related Conditions & MeSH terms

• Death, Sudden
• Heart Failure
• Sudden Death

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