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Efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension
The study is a prospective, single-center, randomized controlled trial. Specifically, the research focuses on patients with right heart failure due to PAH in the Pulmonary Vascular Ward of Fuwai Hospital. Within 12 hours of admission, subjects were randomly assigned to two groups using the central randomization method. The dose of tolvaptan (15 mg/d) is added to standard therapy (including diuretics) for subjects in group A. Traditional standard therapy (including diuretics) is used for subjects in group B. The treatment lasts for a total of seven days to assess the efficacy and safety of tolvaptan in the treatment of PAH-induced right heart failure. An informed consent form must be signed by each participant in our study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects in group A | Experimental | For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d). |
|
| Subjects in group B | Active Comparator | Subjects in group B receive standard therapy (including furosemide: 20mg-40mg/d). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Within 12 hours of admission, subjects were randomly assigned to two groups using the central randomization method. For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide:20-40mg/d). The treatment lasts for a total of seven days to assess the efficacy and safety of tolvaptan in the treatment of PAH-induced right heart failure. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight( in kilograms ) of 7 days after medication or discharge day(one earlier). | Changes in body weight ( in kilograms ) of 7 days after medication or discharge day(one earlier). | 7 days |
| Changes in urine volume (in milliliters)of 7 days after medication or discharge day(one earlier). | Changes in urine volume ( in milliliters ) of 7 days after medication or discharge day(one earlier). | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood creatinine changes in renal function. | Blood creatinine changes in renal function. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihong Liu | Contact | +861088396590 | zhihongliufuwai@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhihong Liu, MD#PhD | center of pulmonary vascular disease, Fuwai hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| center of pulmonary vascular disease, Fuwai hospital | Recruiting | Beijing | 100041 | China |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Furosemide | Drug | Within 12 hours of admission, traditional standard therapy (furosemide:20-40mg/d) is used for all subjects in our clinical trial. The treatment lasts for a total of seven days. |
|
|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |