Effects of low dose oral tolvaptan add on benefit in patients hospitalized for acute decompensated heart failure: A randomized controlled trial
Phase 4
Completed
- Conditions
- Acute decompensated heart failure is a common condition which increases morbidity and cardiovascular mortality. Most patients often suffer from dyspnea. The main treatments are to treat precipitating causes of AHF and to use diuretics for getting rid of water and salt from the body. Tolvaptan may improve these symptoms.
- Registration Number
- TCTR20210316012
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1 Age more than 18 years
2 Acute decompensated HF
3 Admission within 48 hr
4 Plasma Na less than 145 mEq/L
5 Informed consent
Exclusion Criteria
1 Hemodynamic unstable
2 AKI or advanced ESRD
3 Severe hepatitis
4 Pregnancy or breastfeeding
5 Major surgery within 60 days
6 Hypersensitivity to the active substance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of dyspnea score Baseline and day 3 after treatment Dyspnea score at baseline and day 3
- Secondary Outcome Measures
Name Time Method Body weight reduction, increase serum sodium, urine output Baseline and at day 3 Measurement