Randomised Controlled Crossover Trial of Inhaled Furosemide for Dyspnoea Relief in Advanced Heart Failure - INFOD-HF V1.0

niversity of Oxford0 sites30 target enrollmentMay 17, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced heart failure with reduced ejection fraction (less than or equal to 40%) with significant breathlessness that limits what they are able to do. MRC Dyspnoea Scale =2.
Sponsor: niversity of Oxford
Enrollment: 30
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

May 17, 2018

End Date

November 2, 2019

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\)Patient 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 child bearing potential must be willing to ensure that they use effective contraception during the period they are taking the IMP/placebo and for 48hours after Visit 5\.
•8\) Prescribed regular furosemide or bumetanide tablets for at least 1 month
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0

•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