ADA-HF: A pilot study of the safety and efficacy of acetazolamide in patients admitted to hospital with heart failure

Phase 2

• Conditions: Heart failure with severe venous congestion requiring hospital admission; Circulatory System

• Registration Number: ISRCTN13060336
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 22 January 2024
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

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

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 <8 g/DL) or concurrent severe infection (requiring intravenous antibiotics).
9. SBP <80 mmHg at randomisation
10. Serum sodium (severe hyponatraemia) <130 mmol/L at randomisation
11. Serum potassium (hypokalaemia) <3.5 mmol/L at randomisation
12. Serum chloride (severe hyperchloraemia) >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Difference in serum chloride concentrations measured at day 1 and day 4