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Victorian study of Echocardiographic detection of Left ventricular dysFunction (Vic-ELF)

Use of advanced echocardiographic techniques to select asymptomatic subjects at risk of heart failure for spironolactone therapy to reduce progression to heart failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000116325
Acronym
VicELF
Enrollment
180
Registered
2017-01-23
Start date
2017-04-13
Completion date
2019-02-01
Last updated
2018-09-03

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

Conditions

None listed

Brief summary

Heart failure (HF) is a problem that is assuming epidemic proportions, especially among the elderly. Unfortunately, its clinical diagnosis is associated with late-stage disease, which has a poor prognosis and responds poorly to medical therapy. At present, there is no effective strategy for identifying and preventing HF, with the result that patients present late in the course of the disease where hospitalisation is inevitable and treatment responses are poor. The Vic-ELF study (Victorian Study of Echocardiographic detection of Left ventricular dysfunction) study is a randomised trial to explore the benefits of screening selected patients at risk of developing heart failure. We will do this with a special new imaging technique (strain imaging), in which we at Baker IDI Heart and Diabetes Institute have special expertise. Screening of "at risk" patients with a combination of clinical scores and echo imaging is able to identify patients who are liable to develop HF. The question that now needs to be answered is whether surveillance with GLS could change HF outcomes in at risk patients. We anticipate that the prompt initiation of therapy in these patients that are recognized to have the earliest phase of HF will result in improvement in their functional capacity, and arrest in the subsequent progression to HF.

Interventions

Patients will be randomised into two possible strategies of screening: Advanced imaging vs conventional imaging. Advanced cardiac imaging will involve inclusion of global longitudinal strain and diastolic dysfunction evaluation. The test will be performed by a qualified clinician (usually a sonographer), and the procedure will take about 30 minutes. Individuals in either imaging group who are identified as having Stage B heart failure will be treated with spironolactone as an oral tablet (25m

Patients will be randomised into two possible strategies of screening: Advanced imaging vs conventional imaging. Advanced cardiac imaging will involve inclusion of global longitudinal strain and diastolic dysfunction evaluation. The test will be performed by a qualified clinician (usually a sonographer), and the procedure will take about 30 minutes. Individuals in either imaging group who are identified as having Stage B heart failure will be treated with spironolactone as an oral tablet (25mg) daily for 12 months. Adherence to spironolactone will be monitored by tablet count from empty drug packet return.

Sponsors

Baker IDI Heart and Diabetes Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Aged >65 years with any of; -Diabetes (T2DM), based on self-report including medical management -Obesity (body mass index [BMI] greater than or equal to 30) -High blood pressure (blood pressure greater than 140/90 mmHg, self-reported, including anti-hypertensive medication) -Known non-ischaemic cardiac disease (but not existing heart failure)

Exclusion criteria

- Unable to provide written informed consent to participate in this study -Participating in another clinical research trial where randomized treatment would be unacceptable -History of >moderate valvular heart disease -History of previous heart failure, hypertrophic cardiomyopathy -Current therapy, contraindications, intolerance to mineralocorticoid inhibition -Systolic blood pressure (BP) <110mmHg -Estimated glomerular filtration rate (eGFR) <60 - Baseline New York Heart Association (NYHA) classification >2 - Oncologic life expectancy < 12 months - Inability to acquire interpretable images (identified from baseline echo)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026