Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The P-VALUE-AHF trial is a multicenter, randomized, open-label, parallel-group trial on the diuretic and decongestive effects of different diuretic escalation strategies in patients with acute heart failure and diuretic resistance.

The main aims are

• to compare the diuretic efficacy of three therapeutic strategies in patients with acute heart failure and diuretic resistance.

• to assess the improvement in clinical congestion and to compare the symptom-relief among the different treatment regimens

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stadtspital Zürich
• Collaborator: Ospedale Regionale di Lugano
• Treatments: Acetazolamide; Furosemide; Metolazone

Criteria

Inclusion Criteria:

• Elective or emergency hospital admission with clinical diagnosis of acute heart failure

• One or more clinical signs of volume overload (i.e., peripheral edema, pleural effusion, jugular venous distension)

• Low diuretic efficacy in the first 2 hours after the first standard dose Furosemide i.v. (i.e., urine volume < 300 ml and urine sodium concentration < 70 mmol/L)

• Plasma N terminal-proBNP level at admission > 1000 ng/L

• Signed Informed Consent form

Exclusion Criteria:

• Previous use of intravenous diuretics during the index hospitalization (exception first standard dose Furosemide i.v.)

• Maintenance treatment with Acetazolamide or Metolazone

• Use of any non-protocol defined diuretic agent that cannot be stopped upon study inclusion except for sodium-glucose co-transporter-2 inhibitors (e.g., dapagliflozin, empagliflozin, canagliflozin) and mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone)

• Systolic blood pressure < 90 mmHg

• Expected use of intravenous vasopressors (e.g., noradrenaline, adrenaline), inotropes (e.g., dobutamine, milrinone, levosimendan) at any time point during the study

• Severe chronic kidney disease (estimated glomerular filtration rate < 15 ml/min/1.73 m2) or use of renal replacement therapy at any time before study inclusion

• Severe liver dysfunction or cirrhosis at risk of hepatic encephalopathy

• Severe electrolyte disturbances or metabolic acidosis requiring specific intravenous treatment

• Concurrent diagnosis of acute coronary syndrome requiring urgent revascularization

• History of cardiac transplantation or ventricular assist device

• Allergy, intolerance or other contraindication against one of the study drugs

• Pregnancy or breastfeeding

• Age below 18 years.