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

March 1, 2024 updated by: Julia Gonzalez, Puerta de Hierro University Hospital

SANDI STUDY: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure.

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28222
        • Julia González González
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: 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. It consists of intravenous furosemide, SGLT2 inhibitors and acetazolamide if congestion persist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in natriuresis 48 hours after acetazolamide
Time Frame: 48 hours
Change in natriuresis (mmol) 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).
48 hours

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in renal function 48 hours after acetazolamide administration.
Time Frame: 48 hours
Changes in renal function 48 hours after acetazolamide administration. Creatinine (mg/dL)
48 hours
Ionic (potassium (mmol/L) changes
Time Frame: 48 hours
Ionic (potassium (mmol/L) changes 48 hours after acetazolamide
48 hours
chloride (mmol/L) changes 48 hours after acetazolamide administration
Time Frame: 48 hours
chloride (mmol/L) changes 48 hours after acetazolamide
48 hours
bicarbonate (mmol/L) changes 48 hours after acetazolamide administration
Time Frame: 48 hours
48 hours
Changes in blood pressure 48 hours after administration of acetazolamide
Time Frame: 48 hours
Changes in blood pressure 48 hours after administration of acetazolamide (mmHg)
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Standarized diuretic therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe