Topic: Cardiovascular disease
Conditions
Interventions
Each patient will attend the Cardiovascular Clinical Research Facility at John Radcliffe Hospital 4 times at weekly intervals. During each visit the patient will be randomly allocated to receive four
Sponsors
Nuffield Dept of Obstetrics and Gynaecology, University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. Diagnosed with NYHA stage III or IV heart failure 3. Treated with oral furosemide for at least 3 weeks 4. Ambulatory and clinically stable in the previous 3 months 5. Documented left ventricular ejection fraction (LVEF) of <35%.
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. Individuals who are dehydrated or have significant symptomatic postural hypotension 4. Significant renal impairment (eGFR <15) or anuric 5. Significant hepatic impairment/cirrhosis (Child¬Pugh class C) 6. Addison's disease 7. Digitalis intoxication 8. Porphyria 9. Individuals who are immunocompromised 10. Patient with life expectancy <6 months 11. Patients who are inappropriate for saline 12. Co-existent history of significant chronic obstructive pulmonary disease or asthma or interstitial lung disease or nasal polyps 13. 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 14. Have participated in another research trial involving investigational product in the past 4 weeks 15. Patients who have had an admission to hospital with heart failure within the last 3 months 16. Female patients who are pregnant, lactating or planning pregnancy over the course of trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breathlessness is measured using the visual analogue scale (VAS) before and after the air hunger breathing test (experimentally induced breathlessness.) This breathing test is done both before and after the mist inhalation (either furosemide or saline) on study visits 1, 2, 3 and 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness is measured Dyspnoea-12 questionnaire before and after the air hunger breathing test (experimentally induced breathlessness) before and after the mist inhalation (either furosemide or saline) on study visits 1, 2, 3 and 4 2. Blood concentration of furosemide is directly measured from the blood before and after the mist inhalation (either furosemide or saline) before and after the mist inhalation (either furosemide or saline) on study visits 1, 2, 3 and 4 3. Urine output is measured after the mist inhalation (either furosemide or saline) as an indirect measure of furosemide absorption on study visits 1, 2, 3 and 4 4. Breathlessness is measured using the visual analogue scale (VAS) and Borg scale for breathlessness before and after the exercise test (cardiopulmonary exercise test, CPET or 6 minute walk test, 6MWT) before and after the mist inhalation (either furosemide or saline) on study visits 1, 2, 3 and 4 5. Exercise tolerance/capacity is measured using the distance walked during the 6MWT or peak work rate, peak VO2 consumption and peak heart rate on CPET before and after the mist inhalation (either furosemide or saline) on study visits 1, 2, 3 and 4 6. Blood concentration of cardiac biomarkers are measured directly before and after the exercise test (cardiopulmonary exercise test, CPET or 6 minute walk test, 6MWT) before and after the mist inhalation (either furosemide or saline) on study visits 1, 2, 3 and 4 7. Breathlessness is measured using the VAS and Dyspnoea-12 before and after the mist inhalation (either furosemide or saline) on study visits 1, 2, 3 and 4 | — |
Countries
England, United Kingdom
Outcome results
None listed