Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance (NCT05986773) | Clinical Trial Compass
TerminatedPhase 4
Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance
Stopped: Low recruitment in both centers
Switzerland13 participantsStarted 2023-10-10
Plain-language 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
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 Criteria:
* 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 transplanta…
What they're measuring
1
Diuretic efficacy after 6h
Timeframe: 6 hours after administration of the study-specific diuretic regimen