Effect of acetazolamide and furosemide in combination for acute heart failure with volume overload under sodium glucose co-transportor 2 inhibitor

JRCT ID: jRCTs031230483

Registered date:29/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute heart failure
• Date of first enrollment: 29/11/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

A patient who meets inclusion criteria, and has provided written informed consent to participate in this study, will be randomly assigned into 2 groups as shown below.
[treatment group (Acetazolamide and furosemide group)]
Addition to conventional heart failure treatment with intravenous furosemide, acetazolamide 500 mg is administered intravenously once daily for 3 days.
[Control group (Furosemide group)]
Conventional heart failure treatment with intravenous furosemide.

Outcome(s)

• Primary Outcome: Cumulative natriuresis for three days

Secondary Outcome

[Efficacy]
Body weight
Urine volume
NT-proBNP
Visual analogue scale
Length of hospitalization
[Safety]
adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) A patient aged 18 years or older at the time of enrollment.
2) A patient hospitalized for acute heart faiure based on Framingham criteria.
3) NT-proBNP > 1000pg/mL or BNP > 250pg/mL
4) A patient who has clinical sign of volume overload. (edema, pleural effusion, ascites or juglar vein retension).
5) A patients who have taken sodium glucose co-transportor 2 inhibitors (dapagliflozin or empagliflozin) for at least 1 month.
6) A patient who has provided written informed consent to participate in this study (if the patient can not sign by oneself, it is acceptable that a family or a person following a family writes on behalf).

Exclude criteria

1) Receipt of acetazolamide maintenance therapy or intolerance for acetazolamide
2) Type 1 diabetes
3) Symptomatic hypotension
4) A Patient expected to receive intravenous inotropes
5) A history of acute coronary syndrome, stroke or transient ischemic attack within 3 months before screening.
6) A history of allergy for sodium glucose co-transportor 2 inhibitor or acetazolamide
7) Restrictive cardiomyopathy, active myocarditis or hypertrophic obstructive cardiomyopathy
8) Na >145 mEq/L, Na < 130 mEq/L or K < 3.0 mEq/L
9) Severe hepatic dysfunction (Child-Pugh class C)
10) Severe chronic kidney disease (Cre > 3.5mg/dL, eGFR < 20mL/min/1.73m2)
11) Anurea or hypourea (daily urine output < 400mL)
12) Renal replacement therapy
13) Pregnant, possibly pregnant, within 28 days postpartum or nursing women
14) A patient whom the investigator considers to be ineligible as a subject

Related Information

• Primary Sponsor: Iwahana Togo
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)