Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction

• Status: Not yet recruiting
• Trial end date: 2023-02-26
• Target enrollment: 0
• Participant gender: All

Summary

Renal dysfunction, which comprises 10%-40% of acute heart failure patients (AHF), plays an important role in diuretic resistance mechanism. DR-AHF was designed to demonstrate the effectiveness of early tolvaptan (a vasopressin-2 receptor antagonist) add-on therapy in acute heart failure patients with renal dysfunction and clinical evidence of loop diuretic resistance.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gia Dinh People Hospital
• Collaborator: Otsuka Pharmaceutical Vietnam
• Treatments: Arginine Vasopressin; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Tolvaptan; Vasopressins

Criteria

Inclusion Criteria:

• Admitted to hospital with a primary diagnosis of acute heart failure with wet-warm phenotype

• Cumulative urine volume output < 300ml within 2 hours after the first dose of intravenous furosemide

• eGFR at admission 15-60ml/min/1.73m2

Exclusion Criteria:

• Acute coronary syndrome

• Anuria

• Sepsis

• Consciousness impairment

• Pregnant or breastfeeding women

• Severe valvular heart diseases (severe valvular stenosis or regurgitation)

• Admission sodium level > 140 mEq/L

• Serum total bilirubin > 3 mg/dL

• Serum potassium > 5.5 mmol/L

• Allergy or contraindication for tolvaptan

• Emergency indication for hemodialysis

• Cardiogenic shock or mechanical circulation support