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โ† Trials
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Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload

RecruitingPhase 3Ages 18 Years - anyAllJohannes Grand
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In plain words

What the trial is, and whether it could suit you

This trial aims to identify the best strategy for treating acute heart failure (AHF) with volume overload in patients at risk of diuretic resistance. It is a double-blinded, randomized, controlled, multicenter study comparing loop-diuretics combined with metolazone, loop-diuretics combined with acetazolamide, and loop-diuretics with matching placebos. Eligible participants are adults aged 18 years or older who are hospitalized with AHF and have clinical signs of congestion and a risk of diuretic resistance. The primary outcome is the number of days alive and out of hospital through day 30. Secondary outcomes are clinical benefit at 30 days, assessed using a hierarchical win ratio; days alive and out of hospital through day 90; and the duration of the index hospital admission. The trial aims to enroll 939 participants across three treatment arms (313 per arm). The sample size is based

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 18 years 2. Acute hospital admission with a clinical diagnosis of acute heart failure with 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 โ‰ฅ120 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. 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 5. Known allergy to any of the used drugs 6. Severe hypokalemia (\<2.5 mmol/l) or severe hyponatremia (\<125 mmol/l) 7. Severe hepatic impairment defined as an INR \>1.5 (not due to anticoagulant therapy) and/or a Child-Pugh score โ‰ฅB7 8. Known pregnancy
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What it tests

  • Acetazolamide
  • Metolazone 2.5 MG
  • Double-placebo
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Where

6 sites
Amager-Hvidovre Hospital
Hvidovre, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense C, Denmark
Zealand University Hospital
Roskilde, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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