Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging

NCT01522378 | Terminated Phase 1 FDA Drug

• 1 other identifier: 11-006296
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects were recruited if their healthcare provider decided that they needed treatment with a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. The investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.

Conditions

Congestive Heart Failure

Keywords

cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• Change in 123I-MIBG parameters

  changes in 123I-MIBG parameters with cardiac performance including LVEF, stroke volume (SV), left ventricle (LV) and left atrium (LA) dimension, distance of 6-minute walk, NYHA class, and ventricular arrhythmic burden

  baseline, 6 months

Secondary Outcomes (2)

• Change in submaximal exercise gas exchange

  baseline, 6 months

• Change in Autonomic function

  baseline, 6 months

Study Arms (1)

Biv-ICD

EXPERIMENTAL

Subjects will be imaged with 123 iodine metaiodobenzylguanidine.

Drug: 123 iodine metaiodobenzylguanidine

Interventions

123 iodine metaiodobenzylguanidine DRUG

10 millicurie (mCi) (370 MBq)

Also known as: AdreView

Biv-ICD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic moderate to severe congestive heart failure (CHF) (NYHA class II or IV)
• Left ventricular ejection fraction (LVEF) of 35% or less
• Q wave, R wave and S wave (QRS complex) QRS duration of 120 ms or more
• On optimized anti-heart failure medical regimen
• Meet one of the following indications for ICD
• Survivors of cardiac arrest due to ventricular fibrillation (VF) or ventricular tachycardia (VT) or spontaneous sustained VT
• Nonsustained VT with coronary disease, prior myocardial infarction, LVEF 35% or less, and inducible VF or sustained VT at electrophysiologic study
• LVEF of 30% or less with severe coronary artery disease

You may not qualify if:

• Patient condition is unstable
• Patient is unable to give informed consent
• Not feasible for patient to be followed at Mayo Clinic
• Female in pregnancy and breast feeding

Sponsors & Collaborators

• Mayo Clinic: lead
• GE Healthcare: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Yongmei Cha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: January 31, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)