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

NCT ID: NCT05569655

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2022-12-31

Brief Summary

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

Detailed 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.

Conditions

Pulmonary Arterial Hypertension; Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects in group A

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

Group Type: EXPERIMENTAL

Tolvaptan

Intervention Type: 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.

Furosemide

Intervention Type: 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.

Subjects in group B

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

Group Type: ACTIVE_COMPARATOR

Furosemide

Intervention Type: 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.

Interventions

Tolvaptan

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.

Intervention Type: DRUG

Furosemide

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.

Intervention Type: DRUG

Other Intervention Names

Samsca; LASⅨ

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Pulmonary Vascular Disease Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhihong Liu, MD#PhD

Role: STUDY_DIRECTOR

center of pulmonary vascular disease, Fuwai hospital

Locations

center of pulmonary vascular disease, Fuwai hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhihong Liu

Role: CONTACT

zhihongliufuwai@163.com

+861088396590

Facility Contacts

Zhihong Liu, MD,PhD

Role: primary

zhihongliufuwai@163.com

+861088396590

Other Identifiers

Tolvaptan

Identifier Type: -

Identifier Source: org_study_id