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

Heart Failure Clinical Trial

— SANDI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285760
• Other study ID #: 135/23
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Puerta de Hierro University Hospital
• Contact: Julia González González
• Phone: 0034617453693
• Email: juliagfk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Spain	Julia González González	Madrid

Sponsors (7)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in renal function 48 hours after acetazolamide administration.	Changes in renal function 48 hours after acetazolamide administration. Creatinine (mg/dL)	48 hours
Other	Ionic (potassium (mmol/L) changes	Ionic (potassium (mmol/L) changes 48 hours after acetazolamide	48 hours
Other	chloride (mmol/L) changes 48 hours after acetazolamide administration	chloride (mmol/L) changes 48 hours after acetazolamide	48 hours
Other	bicarbonate (mmol/L) changes 48 hours after acetazolamide administration		48 hours
Other	Changes in blood pressure 48 hours after administration of acetazolamide	Changes in blood pressure 48 hours after administration of acetazolamide (mmHg)	48 hours
Primary	Change in natriuresis 48 hours after acetazolamide	Change in natriuresis (mmol) 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).	48 hours
Secondary	Increase in diuresis 48 hours after acetazolamide administration	Increase in diuresis 48 hours after acetazolamide administration (liters)	48 hours
Secondary	Weight difference 48 hours after acetazolamide administration	Weight difference 48 hours after acetazolamide administration (Kg)	48 hours
Secondary	Difference in congestion score 48 hours after acetazolamide administration.	Difference in congestion score 48 hours after acetazolamide administration.	48 hours
Secondary	Difference in ultrasound measurements 48 hours after acetazolamide administration.	Difference in inferior vena cava size (mm), Vexus score and B lines 48 hours after acetazolamide administration.	48 hours