Dyspnoea in patients with heart failure Circulatory System
Conditions
Interventions
All tests will be done at the Cardiovascular Clinical Research Facility, University of Oxford situated within John Radcliffe Hospital, Oxford University Hospitals NHS Trust. 40 patients with advanced
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, aged 18 years or above (there is no upper age limit although the investigator will ensure they have the capacity to understand, consent and have the ability to perform the studies required) 3. Diagnosed with heart failure more than 3 months ago 4. Diagnosed with heart failure with a documented reduced ejection fraction <40% 5. Significant breathlessness that limits what they are able to do. MRC Dyspnoea Scale =2 6. In the Investigator’s opinion, is able and willing to comply with all trial requirements 7. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the period they are taking the IMP/placebo and for 48 hours after Visit 5 8. Prescribed regular furosemide or bumetanide tablets for at least 1 month
Exclusion criteria
Exclusion criteria: 1. Those unable to consent for themselves 2. History of allergic reaction (hypersensitive) to furosemide and/or any of the other ingredients of furosemide or amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole 3. Unplanned heart failure related hospital admission within the last month (unstable heart failure). 4. Patients diagnosed with heart failure within the last 3 months (unstable heart failure) 5. Individuals who are dehydrated or have significant symptomatic postural hypotension 6. Significant renal impairment (eGFR 5.9 or Sodium 150 over the preceding month prior the screening visit. 8. Significant hepatic impairment/cirrhosis (Child-Pugh class C) 9. Addison's disease 10. Digitalis intoxication 11. Porphyria 12. Individuals who are immunocompromised 13. Patient with life expectancy < 6 months 14. Co-existent history of significant chronic obstructive pulmonary disease or asthma or interstitial lung disease or nasal polyps 15. Patients on inhaled B2 agonist therapy 16. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial 17. Have participated in another research trial involving investigational product in the past 4 weeks 18. Female patients who are pregnant, lactating or planning pregnancy over the course of trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 'Air hunger (AH)' rated using a visual analogue scale (VAS) during experimentally induced breathlessness. The VAS is a 10cm line with one end marked as 'no breathlessness at all' and the other end marked as 'worst possible breathlessness.' The participant marks across the line to indicate the level of breathlessness experienced during a test that is designed to make participants feel breathless (air hunger); Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness measured using the Dyspnoea 12 questionnaire at visits 2-5 2. Breathlessness during exercise assessed during the CPET test or 6 minute walk test (observing peak workload, heart rate and oxygen consumption) and also measured using the VAS and/or Borg scale at Visits 2-5 3. Blood biomarkers of heart failure measured at visits 2-5 4. Health related quality of life measured using the MLHFQ questionnaire at Visits 2-5 5. Trait anxiety, depression and fatigue in correlation to breathlessness measured using the trait anxiety questionnaire and center for the epidemiological studies depression scale at Visit 1. The state anxiety questionnaire and fatigue severity score will be measured at Visits 1-5 6. Activity levels assessed using a wearable watch at Visits 2-5 | — |
Countries
England, United Kingdom
Outcome results
None listed