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Recruiting NCT06285760

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

— Observational Heart Failure Persistent Congestion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acetazolamide 500mg.
Who it may be relevant to
Registry conditions: Heart Failure, Persistent Congestion. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Detailed description

The SANDY study is a prospective, multicenter, observational study that will be conducted across 11 hospitals in Spain. It will enroll patients hospitalized for AHF presenting with clinical evidence of fluid overload. The study will evaluate natriuresis at 24 and 48 hours following intravenous acetazolamide administration in patients with persistent congestion despite treatment with intravenous furosemide and an SGLT2i. Upon admission, all patients will receive intravenous loop diuretics according to current European guideline recommendations. For those not previously treated with an SGLT2i, therapy will be initiated within the first 24 hours. Congestion will be reassessed 24 hours after combined loop diuretic and SGLT2i therapy. In line with the ADVOR trial, patients with persistent congestion (ADVOR score \> 1) will receive intravenous acetazolamide (500 mg once daily) for up to two consecutive days.

During hospitalization and follow-up, participants will be encouraged to limit their daily dietary sodium and fluid intake to 3 g and 1500 ml, respectively.

Interventions

  • Drug Acetazolamide 500mg
    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.

Primary outcome measures

  • Change in natriuresis 24 hours after acetazolamide [Time frame: 24 hours]
Secondary outcome measures (10)
  • Increase in diuresis 24 hours after acetazolamide administration [Time frame: 24 hours]
  • Weight difference 24 hours after acetazolamide administration [Time frame: 24 hours]
  • Difference in congestion score 24 hours after acetazolamide administration. [Time frame: 24 hours]
  • Difference in ultrasound measurement of Inferior Vena Cava 24 hours after acetazolamide administration. [Time frame: 24 hours]
  • Change in natriuresis 48 hours after acetazolamide administration [Time frame: 48 hours]
  • Change in diuresis 48 hours after acetazolamide administration [Time frame: 48 hours]
  • Weight difference 48 hours after acetazolamide administration [Time frame: 48 hours]
  • Difference in congestion score 48 hours after acetazolamide administration. [Time frame: 48 hours]
  • Difference in ultrasound measurement of Inferior Vena Cava 48 hours after acetazolamide administration. [Time frame: 48 hours]
  • Change in Vexus score 24 hours after acetazolamide administration. [Time frame: 24 h post acetazolamide administration]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Julia González González — Madrid

Identifiers

NCT: NCT06285760 · 135/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗