Status:
UNKNOWN
Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction
Lead Sponsor:
Gia Dinh People Hospital
Collaborating Sponsors:
Otsuka Pharmaceutical Vietnam
Conditions:
Acute Heart Failure
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief 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 earl...
Detailed Description
This is a single-center, open-label, randomized controlled trial, which will enroll 128 patients hospitalized due to AHF. These patients with wet-warm phenotype whose estimated glomerular filtration r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 26 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04331132
Start Date
December 1 2021
End Date
July 26 2023
Last Update
August 11 2022
Active Locations (1)
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1
Cardiology Department
Ho Chi Minh City, Vietnam, 70000