Finding the best diuretic treatment for acute heart failure with fluid overload

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to identify the most effective treatment strategy for patients with acute heart failure (AHF) experiencing volume overload, particularly those resistant to standard loop-diuretics. It is a double-blinded, randomized, controlled, multicenter trial comparing the efficacy of loop-diuretics combined with either Metolazone or Acetazolamide against loop-diuretics alone. The study will assess the number of days alive and out-of-hospital by day 30 as the primary outcome, along with secondary outcomes such as clinical benefits and quality of life scores. Eligible participants include adults hospitalized with AHF and signs of congestion who are at risk of diuretic resistance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 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 ≥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.

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 ≥B7
8. Known pregnancy

Where it's running

• Amager-Hvidovre Hospital
  Hvidovre, Capital Region of Denmark, Denmark Recruiting
• Aarhus University Hospital
  Aarhus N, Denmark Recruiting
• Bispebjerg Hospital
  Copenhagen, Denmark Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Zealand University Hospital
  Roskilde, Denmark Recruiting
• Odense University Hospital
  Odense C, Denmark Not yet recruiting

Study contacts

• Principal investigator: Johannes Grand, MD, Phd, MPH — Amager-Hvidovre Hospital
• Study coordinator: Johannes Grand, MD, Phd, MPH
• Email: johannes.grand@regionh.dk
• Phone: +4535452121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.