INFOD-HF V1.0
Research type
Research Study
Full title
Randomised Controlled Crossover Trial of Inhaled Furosemide for Dyspnoea Relief in Advanced Heart Failure
IRAS ID
209322
Contact name
Najib Rahman
Contact email
Sponsor organisation
University of Oxford
Eudract number
2017-000124-95
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Research Summary: Patients with heart failure often feel breathless (‘dyspnoea’) which limit daily activities. Furosemide is a prescription drug taken as a tablet or as an injection which makes kidneys produce more urine to remove fluid build-up in heart failure. Over time a third of patients will need more furosemide to get the same response from the kidneys but high level of furosemide can lead to kidney failure. If furosemide is inhaled instead this is known to stop coughing, protect the airways from collapsing and can ease breathlessness by tricking the brain into thinking that more breathing is happening than is the case. This direct action may result in lower doses of furosemide which better protects the kidneys. This study will assess the effect of inhaled furosemide on breathlessness in patients with chronic advanced heart failure.
All tests will be done at the Cardiovascular Clinical Research Facility, University of Oxford situated within John Radcliffe Hospital, Oxford University Hospitals NHS Trust. We will study 40 patients with advanced heart failure who will visit the hospital on five separate occasions and should complete their participation within 5 weeks. At each visit patients will be asked to do a breathing test and an exercise test before and after mist inhalation. In-between visits patients will be asked to inhaled the mist morning and evening at home with one weeks rest in-between. Each mist takes around 15 minutes to inhale.
This study is funded by the British Heart Foundation. The results from this study may lead to improved treatment of breathlessness.Summary of Results: This study assessed whether a commonly used drug which increases the amount the kidneys excrete (called diuretics or furosemide, sometimes called “water tablets”) could be used in a new way to help people with breathlessness due to a common heart condition (heart failure). Heart failure is when the heart muscle does not pump efficiently and means patients can have too much fluid in the body, and this can lead to breathlessness. Drugs such as furosemide are regularly used by mouth and injection in patients with heart failure and help with symptoms. Our study looked at whether using this drug but in an inhaled form (nebuliser) could help to reduce breathlessness in patients with heart failure.
We gave the inhaled drug or a placebo to patients and asked them to exercise and then measured how breathless they were. We then gave the inhaler over a week and again measured how breathless they were. Our results show that the inhaled furosemide did not help with breathlessness either when given in the short term or over a week.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0580
Date of REC Opinion
13 Dec 2017
REC opinion
Further Information Favourable Opinion