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Clinical Trials/CTIS2024-510633-17-00
CTIS2024-510633-17-00
Active, not recruiting
Phase 1

OPTIMAL DIURETIC THERAPIES FOR ACUTE HEART FAILURE WITH VOLUME OVERLOAD

Hvidovre Hospital0 sites939 target enrollmentJanuary 11, 2024

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
acute heart failure
Sponsor
Hvidovre Hospital
Enrollment
939
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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