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Study on the short-term efficacy and safety of early combined application of torvaptan in patients with acute decompensated heart failure accompanied by fluid retention

Study on the short-term efficacy and safety of early combined application of torvaptan in patients with acute decompensated heart failure accompanied by fluid retention

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103241
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Acute heart failure

Interventions

Control group:No intervention
Experimental group:Use Tolvaptan

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Sign the informed consent form and voluntarily cooperate with regular follow-ups; 2. Age > 18 years old; 3. Patients clinically diagnosed with acute decompensated heart failure: (1) Dyspnea at rest or symptoms of dyspnea with mild physical activity (NYHA grade III-IV); (2) Symptoms or signs of congestion (such as sitting breathing, peripheral edema, jugular vein filling, moist rales in the lungs, chest X-ray indicating pulmonary congestion, etc.); (3) NT-proBNP > 450pg/ml(under 50 years old), > 900pg/ml(50-75 years old), > 1800pg/ml(over 75 years old);

Exclusion criteria

Exclusion criteria: 1.Patients allergic to tolvaptan or similar compounds; 2. Install the circulation auxiliary device; 3. Diagnosed with active myocarditis or amyloid cardiomyopathy; 4. Suspected of having reduced circulating blood volume, obstructive hypertrophic cardiomyopathy, or severe aortic valve stenosis; 5. Anuria, urinary disorders caused by urethral stricture, stones, tumors, etc. 6. Systolic blood pressure in the supine position is lower than 90 mmHg(1 mmHg= 0.133 kPa); 7. Any of the following laboratory test values is abnormal: total bilirubin > 2.5 times the upper limit of normal value, serum creatinine > 2.5 times the upper limit of normal value, serum sodium >145 mmol/L, serum potassium >5.5mmoL/L; 8. For other contraindications associated with the use of tolvaptan, refer to the drug instructions; 9. Pregnant women, lactating women, patients who may be pregnant or have pregnancy plans; 10. In addition to the above, the researchers determined that the patients were not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
The change in body weight from the baseline examination to the 8th day;

Secondary

MeasureTime frame
Weight change rate on the 8th day;24-hour urine output;The readmission rate of heart failure within 3 months;

Countries

China

Contacts

Public ContactLiu Ying

The First Affiliated Hospital of Dalian Medical University

18098875801@163.com+86 180 9887 5801

Outcome results

None listed

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