Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging

NCT ID: NCT01522378

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-02-29

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.

Detailed Description

The Specific Aim #1 of this study is to assess, with 123iodine metaiodobenzylguanidine (123I-MIBG imaging), whether cardiac resynchronization therapy (CRT) rebalances and improves the integrity and function of sympathetic nerve terminals in the failing myocardium. The study will test the hypothesis that resynchronization of biventricular contractility attenuates excessive sympathetic drive, and improves autonomic function and cardiac performance.

The Specific Aim #2 of this study is to determine the relationship between 123I-MIBG labeling of sympathetic activity and physiological measures of cardiopulmonary and autonomic function. This aim is to test the hypothesis that impaired cardiac sympathetic activity, determined by 123I-MIBG imaging will be associated with poorer submaximal exercise gas exchange (higher ventilation - carbon dioxide (CO2) slopes, low end tidal CO2, reduced oxygen pulse and a more rapid frequency response) as well as reduced heart rate power spectral frequencies, a blunted response to positional changes and a delayed heart rate recovery.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biv-ICD

Subjects will be imaged with 123 iodine metaiodobenzylguanidine.

Group Type: EXPERIMENTAL

123 iodine metaiodobenzylguanidine

Intervention Type: DRUG

10 millicurie (mCi) (370 MBq)

Interventions

123 iodine metaiodobenzylguanidine

10 millicurie (mCi) (370 MBq)

Intervention Type: DRUG

Other Intervention Names

AdreView

Eligibility Criteria

Inclusion Criteria

1. Chronic moderate to severe congestive heart failure (CHF) (NYHA class II or IV)

2. Left ventricular ejection fraction (LVEF) of 35% or less

3. Q wave, R wave and S wave (QRS complex) QRS duration of 120 ms or more

4. On optimized anti-heart failure medical regimen

5. 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

Exclusion Criteria

1. Patient condition is unstable

2. Patient is unable to give informed consent

3. Not feasible for patient to be followed at Mayo Clinic

4. Female in pregnancy and breast feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Yong-Mei Cha

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongmei Cha, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

11-006296

Identifier Type: -

Identifier Source: org_study_id