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Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging

Primary Purpose

Congestive Heart Failure

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
123 iodine metaiodobenzylguanidine
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring cardiac resynchronization therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Indications for Biv-ICD implantation

  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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biv-ICD

Arm Description

Subjects will be imaged with 123 iodine metaiodobenzylguanidine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in submaximal exercise gas exchange
Subjects will perform simplified low intensity cardiopulmonary exercise testing in our laboratory where they breathe for 1 min at rest, perform graded step exercise, increasing from 60, 90, 120 steps per minute until achieving a perceived exertion of 12-14 on the 6-20 Borg scale. This will be followed by a 1 min recovery. Subjects will be instrumented with ECG, pulse oximeter and breathe on a mouthpiece where ventilation, oxygen and carbon dioxide are measured continuously to calculate the desired parameters of ventilatory efficiency (VE/VCO2), PetCO2 and oxygen pulse (O2Pulse) on a breath by breath basis.
Change in Autonomic function
In addition to the simplified submaximal step test, subjects will also perform a simplified battery of tests for autonomic function. This will include supine to upright measures of heart rate and heart rate variability (HRV), paced breathing (slow to faster frequencies) as well as tracking HRV and responses to the increased metabolic demands of exercise and into recovery.

Full Information

First Posted
January 27, 2012
Last Updated
April 24, 2017
Sponsor
Mayo Clinic
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01522378
Brief Title
Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging
Official Title
Cardiac Resynchronization and MIBG Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because the funding was withdrawn.
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
cardiac resynchronization therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biv-ICD
Arm Type
Experimental
Arm Description
Subjects will be imaged with 123 iodine metaiodobenzylguanidine.
Intervention Type
Drug
Intervention Name(s)
123 iodine metaiodobenzylguanidine
Other Intervention Name(s)
AdreView
Intervention Description
10 millicurie (mCi) (370 MBq)
Primary Outcome Measure Information:
Title
Change in 123I-MIBG parameters
Description
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
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in submaximal exercise gas exchange
Description
Subjects will perform simplified low intensity cardiopulmonary exercise testing in our laboratory where they breathe for 1 min at rest, perform graded step exercise, increasing from 60, 90, 120 steps per minute until achieving a perceived exertion of 12-14 on the 6-20 Borg scale. This will be followed by a 1 min recovery. Subjects will be instrumented with ECG, pulse oximeter and breathe on a mouthpiece where ventilation, oxygen and carbon dioxide are measured continuously to calculate the desired parameters of ventilatory efficiency (VE/VCO2), PetCO2 and oxygen pulse (O2Pulse) on a breath by breath basis.
Time Frame
baseline, 6 months
Title
Change in Autonomic function
Description
In addition to the simplified submaximal step test, subjects will also perform a simplified battery of tests for autonomic function. This will include supine to upright measures of heart rate and heart rate variability (HRV), paced breathing (slow to faster frequencies) as well as tracking HRV and responses to the increased metabolic demands of exercise and into recovery.
Time Frame
baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Indications for Biv-ICD implantation 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 Exclusion criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongmei Cha, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging

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