Efficacy and safety of tolvaptan in Acute Heart Failure

Efficacy and safety of tolvaptan in acute decompensated heart failure - ESTATE-HF

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/05/003643

Enrollment

Registered

2013-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Acute Heart Failure

Interventions

Intervention1: Tolvaptan 15 mg: Oral tablet Intervention2: Standard therapy plus Tolvaptan : Tablet tolvaptan 15 mg once daily given orally for 5 days Control Intervention1: Placebo: Vitamin B Comple

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender above 18 years of age Diagnosis of acute heart failure within 24 hours of presentation to cardio ICU presenting with dyspnea at rest/minimal exertion and at least one of the following Orthopnea Peripheral edema Elevated JVP Pulmonary rales Congestion on Chest X-ray Willing to give informed consent

Exclusion criteria

Exclusion criteria: Systolic blood pressure Serum sodium >136mEq/L Serum creatinine > 3 mg/dl History of acute coronary syndrome in the past 4 weeks Valvular heart disease Pregnant women Breast feeding women Terminal illness due to other causes

Design outcomes

Primary

Measure	Time frame
Improvement in Likert score at end of study period Reduction in body weight at end of study period Adverse events Timepoint: 5 days and 30 days	—

Secondary

Measure	Time frame
MortalityTimepoint: 1 month	—

Countries

India

Contacts

Public ContactDr Melvin George

SRM Medical College Hospital & Research Centre

melvin.srm@rediffmail.com919894133697

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026