use of oxygen in heart failure with preserved ejection fraction
Research type
Research Study
Full title
Randomised, cross over, single blind, control trial of short term oxygen use during cycle ergometry in patients with chronic heart failure with preserved ejection
IRAS ID
205403
Contact name
Parin Shah
Contact email
Sponsor organisation
R&D department, Hull and East Yorkshire Hospitals NHS Trust
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Many patients with symptoms of shortness of breath and fatigue are diagnosed with heart failure due to a stiff heart. The incidence of this is increasing but to date no studies have shown any treatments to improve the prognosis of patients who suffer with heart failure due to a stiff heart. The use of oxygen in heart failure has become normal practice over the past decade to try and improve symptoms of shortness of breath and fatigue. There have been no studies to date of the use of oxygen in patients suffering from heart failure due to a stiff heart.
With a growing interest in the use of oxygen, the Cochrane review (2010) concluded that the administration of oxygen during a heart attack has limited advantage and may in fact be associated with a higher mortality. The most recent NICE guidance regarding chronic heart failure updated in 2010 do not discuss the role of oxygen therapy which further highlights the need for clarification regarding the disparity between guidelines and clinical practice. It is therefore appropriate that the role of oxygen should also be further evaluated in the context of heart failure due to stiff heart.
The proposed crossover randomized study is a pilot to investigate the effects of short term administration of oxygen has on exercise capacity in patients with a stiff heart. Following informed consent, patients will complete exercise sessions on a bike ergo meter using a standardized protocol whilst receiving 1 concentration of oxygen randomized between (21, 28 & 40%) given through a standard Venturi mask. Participants will be asked to return to the department once weekly over a further 2 weeks to undergo exercise sessions with the remaining 2 oxygen concentrations.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
16/YH/0272
Date of REC Opinion
20 Jul 2016
REC opinion
Further Information Favourable Opinion