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

NCT06285760 | Recruiting DMC FDA Drug

• 1 other identifier: 135/23
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure; Persistent Congestion

Keywords

Acetazolamide

Outcome Measures

Primary Outcomes (1)

• Change in natriuresis 24 hours after acetazolamide

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

  24 hours

Secondary Outcomes (10)

• Increase in diuresis 24 hours after acetazolamide administration

  24 hours

• Weight difference 24 hours after acetazolamide administration

  24 hours

• Difference in congestion score 24 hours after acetazolamide administration.

  24 hours

• Difference in ultrasound measurement of Inferior Vena Cava 24 hours after acetazolamide administration.

  24 hours

• Change in natriuresis 48 hours after acetazolamide administration

  48 hours

Other Outcomes (13)

• Changes in renal function 24 hours after acetazolamide administration.

  24 hours

• Ionic (potassium (mmol/L) changes

  24 hours

• chloride (mmol/L) changes 24 hours after acetazolamide administration

  24 hours

Study Arms (1)

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)

Drug: Acetazolamide 500mg

Interventions

Acetazolamide 500mg 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.

Hospitalized heart failure patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for heart failure with persistent findings of residual congestion who meet the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• Systolic blood pressure \<90 mmHg or mean arterial pressure \< 65 mmHg.
• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead
• Hospital Clinic of Barcelona: collaborator
• Hospital Central de la Defensa Gómez Ulla: collaborator
• Hospital Vall d'Hebron: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• University Hospital of Girona Dr. Josep Trueta: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator

Study Sites (1)

Julia González González

Madrid, 28222, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Julia González González

CONTACT

0034617453693; juliagfk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 29, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

ES (1)