Status:
RECRUITING
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Lead Sponsor:
Johannes Grand
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Aim to identify the best strategy for treating acute heart failure (AHF) with volume overload, particularly focusing on patients resistant to standard loop-diuretics. The trial is a double-blinded, ra...
Detailed Description
Trial synopsis Title: OPTIMAL DIURETIC THERAPIES FOR ACUTE HEART FAILURE WITH VOLUME OVERLOAD - A RANDOMIZED CLINICAL TRIAL Background: Intravenous loop-diuretics have been the key component in trea...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Acute hospital admission with a clinical diagnosis of acute heart failure with volume overload.
- Display risk of diuretic resistance, characterized by:
- Daily loop-diuretics administration for a minimum of 7 days before admission, or
- 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).
- 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.
Exclusion
- Acute coronary syndrome
- Systolic blood pressure \<85 mmHg
- Use of renal replacement therapy or ultrafiltration in-hospital before study inclusion
- Treatment with acetazolamide or metolazone during the index hospitalization prior to randomization
- Known allergy to any of the used drugs
- Severe hypokalemia (\<2.5 mmol/l) or severe hyponatremia (\<125 mmol/l)
- Severe hepatic impairment or liver cirrhosis
- Known pregnancy
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
939 Patients enrolled
Trial Details
Trial ID
NCT06166654
Start Date
September 5 2024
End Date
September 30 2027
Last Update
February 20 2025
Active Locations (3)
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1
Amager-Hvidovre Hospital
Hvidovre, Capital Region of Denmark, Denmark, 2650
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Herlev-Gentofte hospital
Copenhagen, Denmark, 2730