Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPuerta de Hierro University Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients admitted for heart failure with persistent findings of residual congestion who meet the inclusion criteria and none of the exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Acetazolamide 500mg
DrugPatients 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.
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: Hospitalized heart failure patients1 intervention
Trial outcomes
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).
Time frame
24 hoursSecondary outcomes
1
Increase in diuresis 24 hours after acetazolamide administration
Increase in diuresis 24 hours after acetazolamide administration (liters)
Time frame
24 hours2
Weight difference 24 hours after acetazolamide administration
Weight difference 24 hours after acetazolamide administration (Kg)
Time frame
24 hours3
Difference in congestion score 24 hours after acetazolamide administration.
Difference in congestion score 24 hours after acetazolamide administration using ADVOR congestion score. It is a 0-10 scale used in the ADVOR trial to objectively quantify volume overload in acute heart failure, based on three components: peripheral edema scored from 0 to 4 points, pleural effusion from 0 to 3 points, and ascites from 0 to 3 points. A total score of 0 represents the absence of measurable congestion, while the maximum of 10 indicates severe, multisite fluid accumulation. Higher ADVOR scores reflect more severe congestion.
Time frame
24 hours4
Difference in ultrasound measurement of Inferior Vena Cava 24 hours after acetazolamide administration.
Difference in inferior vena cava size (mm) assessed by ultrasound, he IVC is visualized in the subcostal long-axis view, and its diameter is measured about 1-2 cm from its junction with the right atrium, 24 hours after acetazolamide administration
Time frame
24 hoursOther outcomes
1
Changes in renal function 24 hours after acetazolamide administration.
Changes in renal function assessed by differences in serum creatinine (mg/dL)24 hours after acetazolamide administration.
Time frame
24 hours2
Ionic (potassium (mmol/L) changes
Ionic (potassium (mmol/L) changes 24 hours after acetazolamide
Time frame
24 hours3
chloride (mmol/L) changes 24 hours after acetazolamide administration
chloride (mmol/L) changes 24 hours after acetazolamide
Time frame
24 hours4
bicarbonate (mmol/L) changes 24 hours after acetazolamide administration
bicarbonate (mmol/L) changes 24 hours after acetazolamide administration
Time frame
24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Puerta de Hierro University Hospital
Lead sponsor
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
Source ClinicalTrials.gov