Key result
Planned HARMONIOUS trial tests if POCUS-guided management reduces heart failure deteriorations versus standard care.
Why the study?
Heart failure is common and challenging to manage in nursing homes, but whether point-of-care ultrasonography-guided management improves outcomes over clinical examination remains unproven.
Does point-of-care ultrasonography-guided management reduce heart failure deterioration in nursing home residents with heart failure?
RCT (n=90)
Open-label
Block randomization (block n=10)
Yes
Does point-of-care ultrasonography-guided management reduce heart failure deterioration in nursing home residents with heart failure?
This trial design aims to evaluate whether point-of-care ultrasonography-guided management reduces heart failure deterioration in nursing home residents.
Planned HARMONIOUS RCT will test POCUS-guided HF care in nursing homes; extends randomized evidence to an underserved elderly population.
INTRODUCTION: Heart failure is common in the nursing home population and presents many diagnostic and therapeutic challenges. Point-of-care ultrasonography is a bedside method that can be used to assess volume status more reliably than clinical examination. This trial was conceived to test whether point-of-care ultrasonography-guided management improves heart failure outcomes among nursing home residents. METHODS: Nursing home residents with heart failure will be enrolled in a multi-centre, prospective, randomised controlled trial. Residents will first be screened for heart failure. Patients with heart failure will be randomised in 1:1 fashion into two groups. Nursing home physicians will adjust diuretic therapy according to volume status for six months. Point-of-care ultrasonography will be used in the test group and clinical examination in the control group. The primary endpoint will be heart failure deterioration, defined as a composite of any of the following four events: the need for an intravenous diuretic application, the need for an emergency service intervention, the need for unplanned hospitalisation for non-injury causes, or death from whatever cause. EXPECTED RESULTS: The expected prevalence of heart failure among nursing home residents is above 10%. Point-of-care ultrasonography-guided heart failure management will reduce the number of deteriorations of heart failure in the nursing home population. CONCLUSION: This study will explore the usefulness of point-of-care ultrasonography for heart failure management in the nursing home population.
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Homar et al. (2020) conducted an RCT in Heart failure (n=90). Point-of-care ultrasonography (POCUS)-guided management vs. Clinical examination-guided management (standard care) was evaluated on Heart failure deterioration (composite of need for intravenous diuretic, emergency service intervention, unplanned hospitalisation for non-injury causes, or death). The HARMONIOUS trial is a planned randomized controlled trial designed to evaluate whether point-of-care ultrasonography-guided management reduces heart failure deteriorations compared to standard clinical care in nursing home residents.
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