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Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01522378
Recruitment Status : Terminated (The study was terminated because the funding was withdrawn.)
First Posted : January 31, 2012
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Yong-Mei Cha, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: 123 iodine metaiodobenzylguanidine Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Resynchronization and MIBG Imaging
Study Start Date : February 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Biv-ICD
Subjects will be imaged with 123 iodine metaiodobenzylguanidine.
 Drug: 123 iodine metaiodobenzylguanidine
10 millicurie (mCi) (370 MBq)
Other Name: AdreView


Outcome Measures
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Primary Outcome Measures :
  1. Change in 123I-MIBG parameters [ Time Frame: baseline, 6 months ]
    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 :
  1. Change in submaximal exercise gas exchange [ Time Frame: baseline, 6 months ]
    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.

  2. Change in Autonomic function [ Time Frame: baseline, 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522378


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
GE Healthcare
Investigators
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Principal Investigator: Yongmei Cha, MD Mayo Clinic
More Information
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Responsible Party: Yong-Mei Cha, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01522378    
Other Study ID Numbers: 11-006296
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Yong-Mei Cha, Mayo Clinic:
cardiac resynchronization therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
3-Iodobenzylguanidine
 Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals