Clinical trial NCT01522378: Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging
Official title: Cardiac Resynchronization and MIBG Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Congestive Heart Failure
Keywords: cardiac resynchronization therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2012-01-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in 123I-MIBG parameters
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change in submaximal exercise gas exchange
timeFrame: baseline, 6 months
measure: Change in Autonomic function
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yongmei Cha, MD
role: PRINCIPAL_INVESTIGATOR
References: