Safety and Effectiveness of Outpatient Based Acute Heart Failure Care
Research type
Research Study
Full title
Safety and Effectiveness of Outpatient Based Acute Heart Failure Care (compared with inpatient management): A Pilot Randomised Controlled Study
IRAS ID
212378
Contact name
Kenneth Y-K. Wong
Contact email
Sponsor organisation
Blackpool Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Safety and Effectiveness of Outpatient based Acute Heart Failure Care- A Pilot Study.
Many healthcare providers assume that intravenous diuretic treatment for patients with acute heart failure (AHF) is safe and effective whether delivered as an inpatient or outpatient. However, data supporting that comes entirely from observational studies, which suffer from potential bias. A randomised controlled trial comparing the two modes of care is essential to gain evidence to justify more widespread investment in outpatient based AHF care.We aim to conduct a single-centre pilot study at Blackpool Victoria Hospital and recruit 100 patients over 12-24 months to demonstrate feasibility for a larger multicentre randomised controlled trial.
Patients within 72 hours of presenting with fluid retention characterised by pitting oedema at least to just below the knees, or those with acute pulmonary oedema who no longer have a new requirement of supplementary oxygen, expected to require at least 2 further days of intravenous diuretic, with investigations confirming ventricular impairment, would be invited to participate. Patients are excluded if they have comorbidities that warrant hospitalization, if they cannot attend the treating centre daily or if they lack capacity to consent.
Patients randomised to the inpatient group would receive intravenous furosemide (a diuretic) as an inpatient. The outpatient group would be discharged and attend the ambulatory care facility (in hospital or community) daily for further outpatient based acute heart failure treatment.
If a patient in the outpatient group develops any serious adverse event which necessitates hospitalisation, then the patient would cross over to the “inpatient” group.
Admissions with acute heart failure are costly to patients, their carers and the health service. We expect this pilot study to reduce the length of hospital stay plus evaluate the clinical effectiveness, safety and cost effectiveness of outpatient based acute heart failure treatment.
REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0645
Date of REC Opinion
10 May 2018
REC opinion
Further Information Favourable Opinion