Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)
Recruiting · NCT06285760 · Observational (researchers observe without assigning treatment) · Lead sponsor: Puerta de Hierro University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Acetazolamide 500mg
What this trial is about
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).
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Julia González González - Madrid, Spain