Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-29 @ 3:01 AM
Study NCT ID:
NCT06285760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in renal function 48 hours after acetazolamide administration.', 'timeFrame': '48 hours', 'description': 'Changes in renal function 48 hours after acetazolamide administration. Creatinine (mg/dL)'}, {'measure': 'Ionic (potassium (mmol/L) changes', 'timeFrame': '48 hours', 'description': 'Ionic (potassium (mmol/L) changes 48 hours after acetazolamide'}, {'measure': 'chloride (mmol/L) changes 48 hours after acetazolamide administration', 'timeFrame': '48 hours', 'description': 'chloride (mmol/L) changes 48 hours after acetazolamide'}, {'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', 'description': 'Changes in blood pressure 48 hours after administration of acetazolamide (mmHg)'}], 'primaryOutcomes': [{'measure': 'Change in natriuresis 48 hours after acetazolamide', 'timeFrame': '48 hours', 'description': 'Change in natriuresis (mmol) 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).'}], 'secondaryOutcomes': [{'measure': 'Increase in diuresis 48 hours after acetazolamide administration', 'timeFrame': '48 hours', 'description': 'Increase in diuresis 48 hours after acetazolamide administration (liters)'}, {'measure': 'Weight difference 48 hours after acetazolamide administration', 'timeFrame': '48 hours', 'description': 'Weight difference 48 hours after acetazolamide administration (Kg)'}, {'measure': 'Difference in congestion score 48 hours after acetazolamide administration.', 'timeFrame': '48 hours', 'description': 'Difference in congestion score 48 hours after acetazolamide administration.'}, {'measure': 'Difference in ultrasound measurements 48 hours after acetazolamide administration.', 'timeFrame': '48 hours', 'description': 'Difference in inferior vena cava size (mm), Vexus score and B lines 48 hours after acetazolamide administration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acetazolamide'], 'conditions': ['Heart Failure', 'Persistent Congestion']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted for heart failure with persistent findings of residual congestion who meet the inclusion criteria and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted for acute heart failure and ≥ 1 clinical sign of volume overload (edema, ascites, or pleural effusion).\n* NTproBNP levels \\>1000 pg/mL or BNP \\>250 ng/mL on admission.\n* 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.\n\nExclusion Criteria:\n\n* Systolic blood pressure \\<90 mmHg or mean arterial pressure \\< 65 mmHg.\n* Maintenance treatment with acetazolamide/ Treatment with acetazolamide in the month prior to inclusion in the study.\n* Anticipated need for intravenous inotropes, vasopressors or nitroprusside during the study.\n* Contraindication to ISGLT2.\n* Type 1 diabetes mellitus\n* GFR \\< 20 ml/min/m2 or renal replacement therapy/ultrafiltration at any time prior to the study.\n* Anticipated exposure to nephrotoxic agents, such as iodinated contrast during admission.\n* Concurrent diagnosis of acute coronary syndrome.\n* History of congenital heart disease requiring surgical correction.\n* History of cardiac transplantation and/or ventricular assist device.\n* Pregnant or breastfeeding patients.\n* Inability to adequately collect diuresis.\n* Serum potassium less than 3.5 mEq/L.\n* Venous pH \\<7.30\n* Severe aortic stenosis or obstructive hypertrophic cardiomyopathy.\n* Sulfonamide allergy, liver cirrhosis, renal lithiasis.'}, 'identificationModule': {'nctId': 'NCT06285760', 'acronym': 'SANDI', 'briefTitle': 'Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'SANDI STUDY: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure.', 'orgStudyIdInfo': {'id': '135/23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalized heart failure patients', 'description': '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.', 'interventionNames': ['Drug: Standarized diuretic therapy']}], 'interventions': [{'name': 'Standarized diuretic therapy', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Hospitalized heart failure patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Julia González González', 'role': 'CONTACT', 'email': 'juliagfk@gmail.com', 'phone': '0034617453693'}], 'facility': 'Julia González González', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Julia González González', 'role': 'CONTACT', 'email': 'juliagfk@gmail.com', 'phone': '0034617453693'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Hospital Central de la Defensa Gómez Ulla', 'class': 'OTHER'}, {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, {'name': 'University Hospital of Girona Dr. Josep Trueta', 'class': 'NETWORK'}, {'name': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist', 'investigatorFullName': 'Julia Gonzalez', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}