Heart failure with severe venous congestion requiring hospital admission Circulatory System
Conditions
Interventions
Patients will be randomised in 1:1 ratio using an online tool to receive oral acetazolamide 250mg twice per day plus usual care or usual care alone over a 4-day period. Usual care must involve intrave
Sponsors
Hull University Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >18 years of any gender and able to give informed consent (females of child bearing age must consent to and have a negative pregnancy test prior to randomisation) 2. Heart failure of any aetiology 3. Admitted to hospital with a primary diagnosis of peripheral oedema caused by heart failure and deemed by treating clinicians to require treatment with intravenous diuretic. 4. Patients are considered eligible as long as they are deemed to require standard of care (10mg per hour furosemide infusion). 5. Patients whose medications have been discontinued for other reasons >1 week previously may be considered eligible. These medications include; high dose aspirin (>500mg / day), methotrexate, lithium, Sando-K®, sodium bicarbonate, other sodium tablets, oral steroids, or sodium valproate. 6. Able to give informed written consent to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Unable to give informed written consent 2. Allergy or contraindication to carbonic anhydrase inhibitors, or are taking another medication (other than loop diuretic) that has a diuretic effect such as bendroflumethiazide, metolazone or sodium-glucose linked transporter-2 inhibitors. 3. Patient thought to be at end-of-life 4. Concurrently taking thiazide (or thiazide-like) diuretic or sodium-glucose linked transporter-2 inhibitor 5. Concurrently taking high dose aspirin (>500 mg/day), methotrexate, lithium, or sodium valproate – risk of drug interactions with ACZ 6. Concurrently taking Sando-K®, oral sodium bicarbonate, or other sodium tablets – confounding electrolyte analysis 7. Concurrently taking oral steroids – confounding diuretic analysis 8. Peripheral oedema due to heart failure that has been triggered by an underlying illness such as severe anaemia (haemoglobin 110 mmol/L at randomisation 13. Severe renal dysfunction with an eGFR (estimate glomerular filtration rate) result of <30 ml/min calculated by the Cockcroft-Gault formula 14. Pregnant or intends to become pregnant whilst taking part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Difference in mean net fluid loss daily and over a 4 day period: total volume intake in millilitres (mL) – total volume passed as urine in mL 2. Difference in serum chloride concentrations measured at day 1 and day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily weight measured in kilograms at baseline, 24 hours, 48 hours, 72 hours, and 96 hours 2. Serum concentrations of sodium, bicarbonate, potassium, urea, and creatinine measured at baseline, 24 hours, 48 hours, 72 hours, and 96 hours 3. Urinary electrolyte concentrations measured twice during the trial over a 24 hour period between 24 to 48 hours, and 72 to 96 hours 4. Clinical assessment of congestion measured by presence and severity of peripheral oedema, lung crackles, raised jugular venous pulse, or ascites at baseline, 24 hours, 48 hours, 72 hours, and 96 hours 5. Breathlessness measured using a Likert scale baseline, 24 hours, 48 hours, 72 hours, and 96 hours 6. Inferior vena cava diameter at baseline and 96 hours 7. Time to clinical euvolaemia measured by clinical assessment in the medical record at discharge 8. Time to discharge measured by difference between date of admission and date of discharge taken from the medical record 9. Number and percentage of adverse, serious adverse, and suspected unexpected serious adverse reactions between baseline and 6 months 10. Number and percentage of adverse, and serious adverse events between baseline and 6 months 11. Rate of recruitment to study measured by number of patients randomised as a percentage of the total number of patients screened measured after the last patient is randomised 12. Cause specific rate of drop out after randomisation measured after last patient last visit. 13. Cause specific hospitalisation and / or mortality after 30 and 180 days. | — |
Countries
United Kingdom
Outcome results
None listed