Clinical trial NCT06285760: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)
Official title: SANDI STUDY: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Persistent Congestion
Keywords: Acetazolamide
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Hospital Central de la Defensa Gómez Ulla
name: Hospital Vall d'Hebron
name: Hospital Universitario Ramon y Cajal
name: University Hospital of Girona Dr.Josep Trueta
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
First posted: 2024-02-29
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


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.

Primary outcomes:
measure: Change in natriuresis 48 hours after acetazolamide
timeFrame: 48 hours
Secondary outcomes:
measure: Increase in diuresis 48 hours after acetazolamide administration
timeFrame: 48 hours
measure: Weight difference 48 hours after acetazolamide administration
timeFrame: 48 hours
measure: Difference in congestion score 48 hours after acetazolamide administration.
timeFrame: 48 hours
measure: Difference in ultrasound measurements 48 hours after acetazolamide administration.
timeFrame: 48 hours
Other outcomes:
measure: Changes in renal function 48 hours after acetazolamide administration.
timeFrame: 48 hours
measure: Ionic (potassium (mmol/L) changes
timeFrame: 48 hours
measure: chloride (mmol/L) changes 48 hours after acetazolamide administration
timeFrame: 48 hours
measure: bicarbonate (mmol/L) changes 48 hours after acetazolamide administration
timeFrame: 48 hours
measure: Changes in blood pressure 48 hours after administration of acetazolamide
timeFrame: 48 hours
Locations:
city: Madrid
country: Spain
facility: Julia González González
Study officials:
References: