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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| Hospital Central de la Defensa Gómez Ulla | OTHER |
| Hospital Vall d'Hebron | OTHER |
| Hospital Universitario Ramon y Cajal |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized heart failure patients | 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, including loop diuretic and sodium-glucose cotransporter-2 inhibitors (SGLT2i) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide 500mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in diuresis 24 hours after acetazolamide administration | Increase in diuresis 24 hours after acetazolamide administration (liters) | 24 hours |
| Weight difference 24 hours after acetazolamide administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Ionic (potassium (mmol/L) changes |
Inclusion Criteria:
Exclusion Criteria:
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Patients admitted for heart failure with persistent findings of residual congestion who meet the inclusion criteria and none of the exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia González González | Contact | 0034617453693 | juliagfk@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julia González González | Recruiting | Madrid | 28222 | Spain |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| OTHER |
| University Hospital of Girona Dr. Josep Trueta | NETWORK |
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
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|
Weight difference 24 hours after acetazolamide administration (Kg)
| 24 hours |
| 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. | 24 hours |
| 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 | 24 hours |
| Change in natriuresis 48 hours after acetazolamide administration | Change in natriuresis 48 hours after acetazolamide administration | 48 hours |
| Change in diuresis 48 hours after acetazolamide administration | Change in diuresis 48 hours after acetazolamide administration | 48 hours |
| Weight difference 48 hours after acetazolamide administration | Weight difference 48 hours after acetazolamide administration | 48 hours |
| Difference in congestion score 48 hours after acetazolamide administration. | Difference in congestion score 48 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. | 48 hours |
| Difference in ultrasound measurement of Inferior Vena Cava 48 hours after acetazolamide administration. | Difference in inferior vena cava size (mm) assessed by ultrasound. The 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, 48 hours after acetazolamide administration | 48 hours |
| Change in Vexus score 24 hours after acetazolamide administration. | Vexus score: The VExUS score (Venous Excess Ultrasound Score) is an ultrasound-based grading system used to assess systemic venous congestion by integrating measurements of the inferior vena cava (IVC) and Doppler patterns of key abdominal veins: the hepatic vein, portal vein, and intrarenal vein. A dilated IVC combined with progressively abnormal venous Doppler waveforms indicates increasing venous congestion. VExUS is typically graded from 0 to 3, where Grade 0 represents no significant congestion and Grade 3 indicates severe venous congestion with markedly abnormal waveforms across multiple veins. Higher VExUS correlates with worse outcomes. | 24 h post acetazolamide administration |
Ionic (potassium (mmol/L) changes 24 hours after acetazolamide
| 24 hours |
| chloride (mmol/L) changes 24 hours after acetazolamide administration | chloride (mmol/L) changes 24 hours after acetazolamide | 24 hours |
| bicarbonate (mmol/L) changes 24 hours after acetazolamide administration | bicarbonate (mmol/L) changes 24 hours after acetazolamide administration | 24 hours |
| Changes in systolic blood pressure 24 hours after administration of acetazolamide | Changes in systolic blood pressure 24 hours after administration of acetazolamide (mmHg) | 24 hours |
| Changes in renal function 48 hours after acetazolamide administration | Changes in renal function assessed by differences in serum creatinine (mg/dL) 48 hours after acetazolamide administration. | 48 hours |
| Ionic (potassium (mmol/L) changes 48 hours after acetazolamide administration | Ionic (potassium (mmol/L) changes 48 hours after acetazolamide | 48 hours |
| Chloride (mmol/L) changes 48 hours after acetazolamide administration | Chloride (mmol/L) changes 48 hours after acetazolamide | 48 hours |
| Bicarbonate (mmol/L) changes 48 hours after acetazolamide administration | Bicarbonate (mmol/L) changes 48 hours after acetazolamide administration | 48 hours |
| Changes in systolic blood pressure 48 hours after administration of acetazolamide | Changes in systolic syblood pressure 48 hours after administration of acetazolamide (mmHg) | 48 hours |
| Change in Vexus score 48 hours after acetazolamide administration. | Vexus score: The VExUS score (Venous Excess Ultrasound Score) is an ultrasound-based grading system used to assess systemic venous congestion by integrating measurements of the inferior vena cava (IVC) and Doppler patterns of key abdominal veins: the hepatic vein, portal vein, and intrarenal vein. A dilated IVC combined with progressively abnormal venous Doppler waveforms indicates increasing venous congestion. VExUS is typically graded from 0 to 3, where Grade 0 represents no significant congestion and Grade 3 indicates severe venous congestion with markedly abnormal waveforms across multiple veins. Higher VExUS correlates with worse outcomes. | 48 hours post acetazolamide administration |
| Change in lung B-lines 24 hours after acetazolamide administration | Change in the number of lung zones with B-lines assessed by lung ultrasound 24 hours after acetazolamide administration. The 8-zone lung ultrasound method evaluates pulmonary congestion by scanning four zones on each hemithorax (anterior and lateral, each divided into upper and lower fields). In each zone, the operator assesses the pleural line and counts B-lines. A zone is considered positive if it contains more than three B-lines | 24 hours |
| Change in lung B-lines 48 hours after acetazolamide administration | Change in the number of lung zones with B-lines assessed by lung ultrasound 48 hours after acetazolamide administration. The 8-zone lung ultrasound method evaluates pulmonary congestion by scanning four zones on each hemithorax (anterior and lateral, each divided into upper and lower fields). In each zone, the operator assesses the pleural line and counts B-lines. A zone is considered positive if it contains more than three B-lines | 48 hours |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |