SHORT Trial
Research type
Research Study
Full title
Efficacy of a Streamlined Heart failure Optimisation pRoTocol for patients with severely impaired left ventricular systolic function, a randomised controlled trial (SHORT trial)
IRAS ID
301966
Contact name
Rudolf Duehmke
Contact email
Sponsor organisation
The Queen Elizabeth Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
The current Covid19 pandemic has led to new safety precautions. These include a limit to the number of patients that can be reviewed face-to-face per clinic session. Furthermore, heart failure patients are far more reluctant to come to hospital for outpatient appointments as they are considered to be at high risk of Covid19 related complications. It is therefore vital to optimise heart failure patients safely with the fewest number of face-to-face appointments over the shortest possible period of time.
Currently, both the guidelines from the European Society of Cardiology and the National Institute of Health and Care Excellence advise that chronic stable heart failure patients with severely impaired left ventricular systolic function should initially be pharmaceutically optimized by starting an angiotensin-converting enzyme inhibitor and a beta-blocker[1,2]. Patients should then be offered a mineralocorticoid receptor antagonist followed by a switch to an angiotensin receptor neprilysin inhibitor if they remained symptomatic. In view of recent publications[3], a sodium-glucose cotransporter 2 inhibitor should also be added. It has been suggested that such an optimisation sequence can however often take up to six months to complete and therefore expose heart failure patients to an unnecessary amount of risk[4] as it may result in both slower and suboptimal heart failure treatment than more streamlined protocols.
This study compares such a more streamlined optimisation protocol to the standard protocol to show whether it does indeed achieve heart failure optimization. Furthermore, the study also hopes to show that remote rather than face-to-face optimisation is possible by utilising remote blood pressure, weight, and renal function monitoring.
References:
[1] Chronic heart failure in adults: diagnosis and management. NICE guideline [NG106]
[2] Acute and Chronic Heart Failure Guidelines. EHJ(2016)
[3] Dapagliflozin in patients with Heart Failure and Reduced Ejection Fraction. NEJM 2019
[4] How should we sequence the treatment for Heart Failure and a Reduced Ejection Fraction? Circ 2021REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0236
Date of REC Opinion
10 Mar 2022
REC opinion
Further Information Favourable Opinion