臨床研究等提出・公開システム

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

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

Iwahana Togo

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Chiba, Japan

adxa2698@chiba-u.jp

Kato Hirotoshi

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Chiba, Japan

+81-432227171

ayma4436@chiba-u.jp

Recruiting

Nov. 29, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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).

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

Both

Acute heart failure

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.

D006333

Cumulative natriuresis for three days

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

+81-43-226-2616

Nov. 20, 2023

No

none