Status:
TERMINATED
Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance
Lead Sponsor:
Stadtspital Zürich
Collaborating Sponsors:
Ospedale Regionale di Lugano
Conditions:
Acute Heart Failure
Diuretic Resistance
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief 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 f...
Detailed Description
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 f...
Eligibility Criteria
Inclusion
- 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 standard screening dose Furosemide i.v. (i.e., urine volume \< 300 ml and urine sodium concentration \< 70 mmol/L)
- Plasma N terminal-proBNP level at enrolment \> 1000 ng/L
- Signed Informed Consent form
Exclusion
- 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.
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05986773
Start Date
October 10 2023
End Date
December 31 2024
Last Update
February 14 2025
Active Locations (1)
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1
Stadtspital Zürich
Zurich, Canton of Zurich, Switzerland, 8063