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Cardiac sympathetic nervous system function and activity as a predictor for appropriate implantable cardioverter defibrillator (ICD) therapy in patients with chronic heart failure.

Sympathetic myocardial activity for the prediction of appropriate ICD discharge in patients with chronic heart failure.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21166
Enrollment
300
Registered
2011-02-04
Start date
2010-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure, sympathetic cardiac activity, 123I-MIBG

Interventions

This is a prospective observational multicenter study. Multivariate Cox proportional hazard regression analysis will be used to identify and evaluate risk factors associated with first occurrence of

Sponsors

Academic Medical Center, University of Amsterdam, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Left ventricular dysfunction (LVEF ≤35%) due to prior MI; 2. Left ventricular dysfunction (LVEF ≤35%) due to non-ischemic heart disease; 3. NYHA functional class II and III; 4. Receiving chronic optimal medical therapy; 5. Reasonable expectation of survival with a good functional status of more than 1 year.

Exclusion criteria

Exclusion criteria: 1. NYHA functional class IV at enrollment; 2. Coronary revascularization within the preceding three months; 3. Myocardial infarction within 40 days prior to enrollment, as evidenced by measurement of cardiac-enzyme levels; 4. Advanced cerebrovascular disease; 5. Childbearing age and not using medically prescribed contraceptive measures; 6. Any condition other than cardiac disease that is associated with a high likelihood of death during the trial; 7. Unwilling to sign the consent form for participation.

Design outcomes

Primary

MeasureTime frame
Increased cardiac sympathetic activity and decreased sympathetic neuronal function as assessed by cardiac 123I-MIBG scintigraphy is associated with increased ICD discharge and anti-tachycardia pacing in patients with CHF and can therefore be used to identify patients who will most likely benefit from ICD implantation.

Contacts

Public ContactHein J. Verberne

Department of Nuclear Medicine Academic Medical Center, F2-238 P.O. Box 22700

h.j.verberne@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)