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

NCT ID: NCT06285760

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-12-31

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 24 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).

Detailed Description

The SANDY study is a prospective, multicenter, observational study that will be conducted across 11 hospitals in Spain. It will enroll patients hospitalized for AHF presenting with clinical evidence of fluid overload. The study will evaluate natriuresis at 24 and 48 hours following intravenous acetazolamide administration in patients with persistent congestion despite treatment with intravenous furosemide and an SGLT2i. Upon admission, all patients will receive intravenous loop diuretics according to current European guideline recommendations. For those not previously treated with an SGLT2i, therapy will be initiated within the first 24 hours. Congestion will be reassessed 24 hours after combined loop diuretic and SGLT2i therapy. In line with the ADVOR trial, patients with persistent congestion (ADVOR score > 1) will receive intravenous acetazolamide (500 mg once daily) for up to two consecutive days.

During hospitalization and follow-up, participants will be encouraged to limit their daily dietary sodium and fluid intake to 3 g and 1500 ml, respectively.

Conditions

Heart Failure; Persistent Congestion

Keywords

Acetazolamide

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hospitalized heart failure patients

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, including loop diuretic and sodium-glucose cotransporter-2 inhibitors (SGLT2i)

Acetazolamide 500mg

Intervention Type: DRUG

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. It consists of intravenous furosemide, SGLT2 inhibitors and acetazolamide if congestion persist.

Interventions

Acetazolamide 500mg

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. It consists of intravenous furosemide, SGLT2 inhibitors and acetazolamide if congestion persist.

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Hospital Central de la Defensa Gómez Ulla

OTHER

Sponsor Role: collaborator

Hospital Vall d'Hebron

OTHER

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

University Hospital of Girona Dr. Josep Trueta

NETWORK

Sponsor Role: collaborator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julia Gonzalez

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Julia González González

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Julia González González

Role: CONTACT

Phone: 0034617453693

Email: juliagfk@gmail.com

Facility Contacts

Julia González González

Role: primary

Other Identifiers

135/23

Identifier Type: -

Identifier Source: org_study_id