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The role of diagnostic imaging in identifying appropriate strategies for heart failure treatment

Stratification of heart failure patients using 123I MIBG SPECT regional analysis compared to standard LVEF based stratification in predicting cardiac event rate and, thus, suitability for implantable defibrilator.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12611000967987
Enrollment
100
Registered
2011-09-09
Start date
2011-09-20
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The study is a prospective follow-up of major cardiac events in patients presenting with confirmed CHF with LVEF of 45% or less and in whom NYHA classification rest in the II or III category. Patients will follow standard management plans informed by their HF classification, LVEF and global mIBG quantitation. The proposed project would allow prospective data to be collected with follow-up to 2 years, and provide an initial validation of our proposed novel 3-D tomographic SPECT based regional quantitation of myocardial uptake and washout of 123I-mIBG against the traditional more established global approaches using planar 2-D imaging. Our assertion is that regional quantitation should provide more accurate risk stratification than the existing global approaches. This information requires up to 24 months follow-up of cardiac events in patients presenting with heart failure. A follow-up to 5 years will be undertaken. Hypothesis: 123I-mIBG SPECT provides stratification of CHF patients most likely to benefit from aggressive management, independently of LVEF. Primary Aims: 1. Determine whether 123I-mIBG is independently predictive of SCD or ICD discharge in CHF patients with LVEF less than or equal to 35%. 2. Determine whether 123I-mIBG is independently predictive of SCD in CHF patients with LVEF greater than 35%.

Interventions

This is an observational study. The condition observed will be cardiac events including sudden cardiac death. The observation will be in the first instance at 1 and 2 years, however, longituinal data to 5 years will also be evaluated.

Sponsors

Dr Geoff Currie
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

LVEF of 45% or less and in whom NYHA classification rest in the II or III category

Exclusion criteria

Cardiac transplantation, chemotherapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026