open-label randomised trial of tolvaptan plus low dose furosemide compared with high dose furosemide in patients with hospitalised heart failure

Not Applicable

• Conditions: - Hospitalised heart failure with or without AKI AKIN stage I who received intermittent furosemide 40- 60mg IV /day if poor response then randomised to two group between tolvaptan plus low dose furose; hospitalised heart failure; tolvaptan

• Registration Number: TCTR20190805001
• Lead Sponsor: thai otsuka pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-05
• Study Completion: 2019-12-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

age> 18 years
hospitalised heart faillure by framingham criteria

Exclusion Criteria

-patient who receive more than two iv dose of furosemide 1 month or oral > 80 mg/day before randomisation
- allergy tolvaptan
- patient with serum sodium > 142 mol/L
- serum K <3.0 mol/l
- CKD > G3B (GFR< 30 by EPI)
- on RRT
- SBP < 90 mmHg
- sepsis or SOFA >= 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
daily bodyweight change and urine volume 1year mean and standard deviation ,student t test

Secondary Outcome Measures

Name	Time	Method
incidence of AKI progression of AKI ,change in serum creatinine 1 year mean and standard deviation ,student t test