RecruitingPhase 4NCT06414759

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

Sponsor

Cairo University

Enrollment

110 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Edema Acute Decompensated Heart Failure Volume Overload

Summary

This study aims to compare two medications, acetazolamide and metolazone, along with loop diuretics, to see which one works better and is safer for patients with ADHF who have volume overload. By comparing these medications, we hope to learn which one can help these patients the most. This will help doctors choose the best treatment for patients with ADHF and volume overload.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria11

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.

Interventions

DRUGAcetazolamide

Acetazolamide is a medication that belongs to the class of carbonic anhydrase inhibitors. It acts by reducing the reabsorption of sodium in the proximal tubules of the kidneys. When combined with loop diuretics, acetazolamide has the potential to enhance the effectiveness of diuretic therapy, thus aiding in the process of decongestion. It will be given 500mg orally, once daily.

DRUGMetolazone

Metolazone is a medication with properties like thiazide diuretics, prescribed for the management of congestive heart failure and hypertension. Its mechanism of action involves blocking the transport of sodium across the epithelium of renal tubules, predominantly in the distal tubules. It will be given 5mg orally, once daily.

DRUGIV Loop Diuretics

IV loop diuretic 2 times the outpatient oral (PO) daily dose, and oral loop diuretics will be stopped. In cases where the patient was not previously on oral diuretics, a starting dose of 40 mg of IV furosemide, IV bumetanide 1 mg or a bolus of 20 mg of IV torsemide can be utilized.