Comparing two diuretics for treating heart failure with fluid overload
Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload
This study tests whether two different diuretics, acetazolamide and metolazone, can help people with heart failure and fluid overload feel better and be safer than current treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza, GZ) |
| Trial ID | NCT06414759 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of two medications, acetazolamide and metolazone, in combination with loop diuretics for patients suffering from acute decompensated heart failure (ADHF) and volume overload. By comparing these treatments, the study aims to determine which medication provides better relief from symptoms and is safer for patients. The findings will assist healthcare providers in selecting the most effective treatment options for managing ADHF with volume overload.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a clinical diagnosis of acute decompensated heart failure exhibiting signs of volume overload.
Not a fit: Patients with acute kidney injury or those experiencing acute pulmonary edema due to increased afterload may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with acute decompensated heart failure, enhancing their recovery and quality of life.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in improving outcomes for patients with heart failure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients with ages ≥ 18 years old, and less than 65 years old. * For both elective and emergency hospital admissions, patients with a clinical diagnosis of ADHF must exhibit at least one clinical sign indicative of volume overload. These signs may include edema (score 2 or higher), ascites confirmed through echography, or pleural effusion confirmed by chest X-ray or echography or rales on auscultation, or jugular venous pressure greater than10 mm Hg. Exclusion Criteria: * Patient diagnosed with acute kidney injury upon hospital admission based on the presence of any of the following criteria: an increase in SCr by at least 0.3 mg/dL within 48 hours, an increase in SCr to at least 2 times the baseline value, known or presumed to have occurred within the prior 7 days, and a urine volume less than 0.5 ml/kg/hour for a duration of 6 hours. * Patients with acute pulmonary edema caused by increased afterload and fluid redistribution to the lungs in the absence or with minimal fluid accumulation. * Anticipated exposure to nephrotoxic agents (such as contrast dye) during hospitalization. * Patients who exhibit anuria or are undergoing renal replacement therapy or ultrafiltration. * Patients with eGFR less than 30 mL/min/1.73m² at the time of screening. * Expected use of intravenous inotropes, vasopressors, or nitroprusside during the study. * Prior cardiac transplantation and/or utilization of a ventricular assist device. * Blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg at the time of recruitment. * Patients who are pregnant or breastfeeding. * Administration of acetazolamide or metolazone within the one-month period preceding randomization. * The usage of any diuretic agent during the treatment phase is not specified in the study protocol, except for mineralocorticoid receptor antagonists.
Where this trial is running
Giza, GZ
- National Heart Institute — Giza, Gz, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed AN Abdelmoaty, B.Sc. Pharmaceutical Sciences
- Email: mohamed.naguib@miuegypt.edu.eg
- Phone: +201146631157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.