NCT06783166 Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure
| NCT ID | NCT06783166 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mansoura University |
| Condition | Acute Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-08-15 with a primary completion date of 2025-07-01.
⚠ 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
This study investigates the comparative clinical outcomes of dapagliflozin, an SGLT-2 inhibitor, versus acetazolamide, a carbonic anhydrase inhibitor, in patients hospitalized with acute heart failure (AHF). The trial aims to assess the effectiveness of these drugs in improving natriuretic and diuretic responses and shortening hospital stays. Dapagliflozin and acetazolamide will be added to standard loop diuretic therapy, and their safety profiles will be evaluated to identify potential side effects. This research seeks to provide evidence for incorporating these drugs into AHF management, with the potential to improve clinical outcomes.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either: * 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure \> 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound. OR * If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above. 2. Randomized within 24 hours of hospitalization for AHF. 3. Planned use of IV loop diuretic therapy during current hospitalization 4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation. Exclusion Criteria: 1. Unable to follow instructions. 2. Treated with any proximal tubular diuretics. 3. Systolic blood pressure of less than 90 mm Hg. 4. An estimated glomerular filtration rate (GFR) of less than 20 ml per 1.73 m2 of body-surface area. 5. Type 1 diabetes mellitus. 6. Dyspnea is primarily due to non-cardiac causes. 7. Cardiogenic shock. 8. Acute coronary syndrome within 30 days prior to randomization. 9. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization. 10. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L). 11. Pregnant or nursing (lactating) women.
Contact & Investigator
Noha Mansour, PhD
PRINCIPAL INVESTIGATOR
Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura
Frequently Asked Questions
Who can join the NCT06783166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06783166 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06783166 currently recruiting?
Yes, NCT06783166 is actively recruiting participants. Contact the research team at hossamsharaaf@gmail.com for enrollment information.
Where is the NCT06783166 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT06783166 clinical trial?
NCT06783166 is sponsored by Mansoura University. The principal investigator is Noha Mansour, PhD at Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, University of Mansoura. The trial plans to enroll 100 participants.
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