OPTIMAL DIURETIC THERAPIES FOR ACUTE HEART FAILURE WITH VOLUME OVERLOAD

Phase 1

Active, not recruiting

• Conditions: acute heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-510633-17-00
• Lead Sponsor: Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 939

Inclusion Criteria

1.Aged 18 years or older. 2.Admitted acutely with a clinical diagnosis of acute heart failure accompanied by volume overload*. 3.Display risk of diuretic resistance, characterized by: 1.Daily loop-diuretics administration for a minimum of 7 days before admission, or 2.Insufficient decongestion observed in the preceding 24 hours (weight reduction <500g or negative fluid balance <1L) despite being treated with high-dose IV loop diuretic (equivalent to =120 mg IV furosemide within 24 hours). 4.Clinical signs of congestion, indicated by one or more of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiological/ultrasonic evidence of pulmonary congestion. *Volume overload is characterized by at least two of the subsequent signs of congestion: a. Clear pitting edema b. Uni- or bilateral pleural effusion c. Ascites d. Pulmonary congestion or edema

Exclusion Criteria

1.Acute coronary syndrome 2.Systolic blood pressure <85 mmHg 3.Use of renal replacement therapy or ultrafiltration in-hospital before study inclusion 4.Treatment with acetazolamide or metolazone during the index hospitalization prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified