Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH

Chinese Pulmonary Vascular Disease Research Group

Status: Enrolling

Conditions: Randomized Controlled Trial; Pulmonary Arterial Hypertension

Treatments: Drug: Tolvaptan; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT05569655

Tolvaptan

Details and patient eligibility

About

Efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who have no serious cerebrovascular, liver, kidney and lung organ and tissue diseases.
• No corticosteroids or immunosuppressive agents had been administered to the - Patients in the three months prior to enrollment in the study.
• Patients voluntarily participated in the study and signed an informed consent form.

Exclusion criteria

• Patients who install the circulation aids.
• Patients who have been diagnosed with active myocarditis or amyloid cardiomyopathy.
• Fasting blood glucose level exceeded 12.21 mmol/L in individuals with uncontrolled diabetes.
• Patients who suffer from anuria, urethral strictures, stones, or tumors caused by urination disorders.
• Patients with acute myocardial infarctions, persistent ventricular tachycardias, or ventricular fibrillations, and cerebrovascular accidents within the first 30 days of the screening period.
• Patients with a history of allergy or specific reactions to benzodiazepines. (Mozavaputan hydrochloride, Benaepril hydrochloride)
• Any of the following laboratory tests were abnormal: serum creatinine> 2.5 times the upper normal value limit, serum sodium> 145 mmol/L, and serum potassium> 5.5 mmol/L.
• Pregnant women, lactating women, or patients who may be pregnant or have pregnancy plans.
• Patients with other contraindications to the use of tolvaptan.
• Patients who have been taking tolvaptan within the first 3 months before inclusion in the study, either when the drug was marketed or when it was being clinically studied.
• Additionally, patients who were judged by the investigators not fit to be enrolled in this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Subjects in group A

Experimental group

Description:

For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d).

Treatment:

Drug: Furosemide

Drug: Tolvaptan

Subjects in group B

Active Comparator group

Description:

Subjects in group B receive standard therapy (including furosemide: 20mg-40mg/d).

Treatment:

Drug: Furosemide