Inhaled furosemide for dyspnoea relief

Not Applicable

Completed

• Conditions: Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Heart Failure; Circulatory System; Heart failure

• Registration Number: ISRCTN11011373
• Lead Sponsor: uffield Dept of Obstetrics and Gynaecology, University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-09
• Study Completion: 2019-01-31
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.