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The Effectiveness and Safety of Tolvaptan on Top of Standard Medication in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Hypertension

The Effectiveness and Safety of Tolvaptan on Top of Standard Medication in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Hypertension

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044467
Enrollment
Unknown
Registered
2021-03-18
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

pulmonary arterial hypertension

Interventions

Control group:Traditional diuretic
Experimental group:Tolvaputan

Sponsors

Center for Pulmonary Vascular Diseases, National Center for Cardiovascular Diseases and Fuwai Hospital, CAMS and PUMC, Beijing(100037), China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. The patient was confirmed by the right heart catheter of the first class of pulmonary hypertension (PAH), hemodynamic compliance: pulmonary artery average pressure (MPAP) >=25mmHg, pulmonary small artery ?pression (PAWP) 15mmHg, PVR3wood units. And there are clinical symptoms and signs of right heart failure: difficulty breathing after activity, lower limb edema, neck vein anger, ascertic water, etc. 3. New York Heart Association (NYHA) heart function rating are III IV; 4. The targeted drugs used to treat PAH are relatively stable; 5. Not combined with serious cerebrovascular, liver, kidney, lung and other organ tissue diseases; 6. No glucosticoids and immunosuppressants were used in the first 3 months of the study; 7. Volunteer to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Installation of cycle aids; (2) Diagnosed as active myocarditis or amyloid cardiomyopathy; (3) Suspected obstruction hypertrophomyopathy, severe aortic stenosis; (4) Poorly controlled diabetes, an empty stomach blood sugar of more than 12.21mmol/L; (5) No urine, urethra stenosis, stones, tumors, etc. caused by urination disorders; (6) Acute myocardial infarction, persistent roomary titration or atrial fibrillation, cerebrovascular accident within 30d before screening; (7) Patients with a history of allergies or specific reactions to benzodiazepines (Mozavaptan hydrochloride, benapri hydrochloric acid); (8) Any of the following laboratories examined abnormalities: serum creatinine> normal limit of 2.5 times, serum sodium >145mmol/L, serum potassium >5.5mmol/L. (9) Pregnant women, lactating women, patients who may be pregnant or have a pregnancy plan; (10) Other taboos associated with the use of Tovaputan; (11) Tovaputan was used in the first 3 months of the study, including listed Tovaputan or in clinical studies. (12) In addition to the above, the researchers determined that patients who participated in this trial were not suitable.

Design outcomes

Primary

MeasureTime frame
weight;The amount of urine;

Secondary

MeasureTime frame
NT-proBNP;the fuction of right heart;

Countries

China

Contacts

Public ContactZhihui Zhao

Center for Pulmonary Vascular Diseases, National Center for Cardiovascular Diseases and Fuwai Hospital, CAMS and PUMC, Beijing(100037), China

zhaozhihui2008cn@yahoo.com+86 01088396985

Outcome results

None listed

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