Inhaled furosemide for dyspnoea relief in advanced heart failure

Phase 2

Completed

• Conditions: Dyspnoea in patients with heart failure; Circulatory System

• Registration Number: ISRCTN14593637
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-28
• Study Completion: 2020-11-04
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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 < 15) or anuric
7. Potassium < 3.0 or > 5.9 or Sodium < 130 or > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified