Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)

Not yet recruiting

• Conditions: Heart Failure; Persistent Congestion
• Interventions: Drug: Standarized diuretic therapy

• Registration Number: NCT06285760
• Lead Sponsor: Puerta de Hierro University Hospital

Brief Summary

The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.

The main question it aims to answer is whether there is a difference in natriuresis 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-02-29
• Status Verified: 2024-03
• Study Start: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients admitted for acute heart failure and ≥ 1 clinical sign of volume overload (edema, ascites, or pleural effusion).
• NTproBNP levels >1000 pg/mL or BNP >250 ng/mL on admission.
• Under treatment with furosemide and iSGLT2 according to European guidelines and indication of association of another diuretic due to residual congestion data defined by ADVOR SCORE>1.

Exclusion Criteria

• Systolic blood pressure <90 mmHg or mean arterial pressure < 65 mmHg.
• Maintenance treatment with acetazolamide/ Treatment with acetazolamide in the month prior to inclusion in the study.
• Anticipated need for intravenous inotropes, vasopressors or nitroprusside during the study.
• Contraindication to ISGLT2.
• Type 1 diabetes mellitus
• GFR < 20 ml/min/m2 or renal replacement therapy/ultrafiltration at any time prior to the study.
• Anticipated exposure to nephrotoxic agents, such as iodinated contrast during admission.
• Concurrent diagnosis of acute coronary syndrome.
• History of congenital heart disease requiring surgical correction.
• History of cardiac transplantation and/or ventricular assist device.
• Pregnant or breastfeeding patients.
• Inability to adequately collect diuresis.
• Serum potassium less than 3.5 mEq/L.
• Venous pH <7.30
• Severe aortic stenosis or obstructive hypertrophic cardiomyopathy.
• Sulfonamide allergy, liver cirrhosis, renal lithiasis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized heart failure patients	Standarized diuretic therapy	Patients hospitalized with decompensated heart failure and fluid overload who require diuretic treatment for relieve of congestion. Standarized diuretic protocol according to guidelines will be applied.

Primary Outcome Measures

Name	Time	Method
Change in natriuresis 48 hours after acetazolamide	48 hours	Change in natriuresis (mmol) 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).

Secondary Outcome Measures

Name	Time	Method
Increase in diuresis 48 hours after acetazolamide administration	48 hours	Increase in diuresis 48 hours after acetazolamide administration (liters)
Weight difference 48 hours after acetazolamide administration	48 hours	Weight difference 48 hours after acetazolamide administration (Kg)
Difference in congestion score 48 hours after acetazolamide administration.	48 hours	Difference in congestion score 48 hours after acetazolamide administration.
Difference in ultrasound measurements 48 hours after acetazolamide administration.	48 hours	Difference in inferior vena cava size (mm), Vexus score and B lines 48 hours after acetazolamide administration.

Trial Locations

Locations (1)

Julia González González; 🇪🇸 Madrid, Spain