Acute Heart Failure Clinical Trial
— P-Value-AHFOfficial title:
Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance (P-Value-AHF): A Multicentre, Randomized, Parallel-group, Open-label Trial
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
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 31, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Stadtspital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Stadtspital Zürich | Ospedale Regionale di Lugano |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Outcomes 1 | Hypotension (SBP< 90 mmHg) with symptoms or requiring therapeutic intervention | 0-24 hours after administration of the study-specific diuretic regimen | |
Other | Safety Outcomes 2 | Increase in serum creatinine >50% from baseline | 0-24 hours after administration of the study-specific diuretic regimen | |
Other | Safety Outcomes 3 | New electrolyte disturbances (sodium < 130mmol/l or > 150mmol/l, potassium < 3.0mmol/l or > 5.5 mmol/l) | 0-24 hours after administration of the study-specific diuretic regimen | |
Primary | Diuretic efficacy after 6h | urine- natrium concentration (mmol/L) | 6 hours after administration of the study-specific diuretic regimen | |
Secondary | Diuretic efficacy after 2h | urine- natrium concentration (mmol/L) | 2 hours after administration of the study-specific diuretic regimen | |
Secondary | Diuretic efficacy after 24h | urine- natrium concentration (mmol/L) | 24 hours after administration of the study-specific diuretic regimen | |
Secondary | Change in clinical congestion | EVEREST congestion score | 0 and 24 hours after administration of the study-specific diuretic regimen | |
Secondary | Change in dyspnea severity | numeric rating scale | 0 and 24 hours after administration of the study-specific diuretic regimen. |
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