Skip to content

Effects of low dose oral tolvaptan add on benefit in patients hospitalized for acute decompensated heart failure: A randomized controlled trial

Effects of low dose oral tolvaptan add on benefit in patients hospitalized for acute decompensated heart failure: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210316012
Enrollment
40
Registered
2021-03-16
Start date
2020-11-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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. Acute decompensated heart failure is a common condition which increases morbidity and cardiovascular mortality. Most patients often suffer from dyspnea. The main treatments are

Interventions

Tolvaptan 7.5 mg oral once daily,Standard treatment
Experimental Drug,No Intervention Drug
Tolvaptan,Control

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Improvement of dyspnea score Baseline and day 3 after treatment Dyspnea score at baseline and day 3

Secondary

MeasureTime frame
Body weight reduction, increase serum sodium, urine output Baseline and at day 3 Measurement

Countries

Thailand

Contacts

Public ContactRatthaphon Chitthai

Department of Internal Medicine, Phramongkutklao Hospital

ratthaphon_chi@hotmail.com0818404632

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026