NCT06285760 Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)
| NCT ID | NCT06285760 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Puerta de Hierro University Hospital |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 64 participants in total. It began in 2024-03-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 24 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06285760 clinical trial?
This trial is open to participants of all sexes, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06285760 currently recruiting?
Yes, NCT06285760 is actively recruiting participants. Contact the research team at juliagfk@gmail.com for enrollment information.
Where is the NCT06285760 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06285760 clinical trial?
NCT06285760 is sponsored by Puerta de Hierro University Hospital. The trial plans to enroll 64 participants.
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