NCT01185756

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 11, 2018

Status Verified

December 1, 2017

Enrollment Period

6.5 years

First QC Date

July 9, 2010

Last Update Submit

January 10, 2018

Conditions

Heart FailureSudden Death

Keywords

Heart failureSudden deathImplantable Cardioverter DefibrillatorMIBG scintigraphy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Sudden cardiac death

    1-3 months

  • Overall mortality

    1-3 months

  • Assessment of the cardiac MIBG uptake ratio for identification of patients at very low risk of severe ventricular arrhythmias.

    every 6 months during 3 years

  • sudden cardiac death

    every 6 months during 3 years

  • Overall mortality

    every 6 months during 2 years

Study Arms (1)

ICD implantation

EXPERIMENTAL

MIBG for diagnostic purpose: MIBG scintigraphy for diagnostic purpose

Radiation: MIBG for diagnostic purpose

Interventions

MIBG for diagnostic purposeRADIATION

All patients will undergo the diagnostic test specific to the study.

ICD implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Bichat - Claude Bernard

Paris, Île-de-France Region, 75018, France

Location

MeSH Terms

Conditions

Heart FailureDeath, Sudden

Interventions

3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsIodobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHydrocarbons, IodinatedHydrocarbons, Halogenated

Study Officials

  • Dominique Le Guludec, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2010

First Posted

August 20, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2017

Study Completion

January 1, 2018

Last Updated

January 11, 2018

Record last verified: 2017-12

Locations

FR(1)