Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload

Launched by CAIRO UNIVERSITY · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different medications, acetazolamide and metolazone, to see which one works better alongside standard diuretics for patients suffering from acute decompensated heart failure (ADHF) and fluid overload. ADHF is a serious condition where the heart suddenly can't pump blood effectively, leading to symptoms like swelling or difficulty breathing due to excess fluid in the body. By comparing these medications, the study aims to find the safest and most effective treatment, helping doctors make better choices for their patients.

To participate in the trial, individuals must be at least 18 years old and diagnosed with ADHF showing signs of fluid overload, such as swelling in the legs or abdomen. However, certain patients may not be eligible, including those with recent kidney issues or serious heart problems. If they join the study, participants will receive one of the medications being tested in addition to regular treatment, and they will be monitored closely for safety and effectiveness. This research is important because it could lead to improved care for people facing this challenging health issue.

Gender

ALL

Eligibility 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.