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

Sponsor

Chinese Pulmonary Vascular Disease Research Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT05569655

Collaborator

(none)

100

Enrollment

Location

Arms

20.8

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension Randomized Controlled Trial	Drug: Tolvaptan Drug: Furosemide	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Arterial Hypertension

Actual Study Start Date :

Apr 6, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects in group A For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d).	Drug: 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. Other Names: Samsca 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. Other Names: LASⅨ
Active Comparator: Subjects in group B Subjects in group B receive standard therapy (including furosemide: 20mg-40mg/d).	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. Other Names: LASⅨ

Arm

Intervention/Treatment

Experimental: Subjects in group A

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

Drug: 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.

Other Names:

Samsca

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.

Other Names:

LASⅨ

Active Comparator: Subjects in group B

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

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.

Other Names:

LASⅨ

Outcome Measures

Primary Outcome Measures

Changes in body weight( in kilograms ) of 7 days after medication or discharge day(one earlier). [7 days]
Changes in body weight ( in kilograms ) 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]
Changes in urine volume ( in milliliters ) of 7 days after medication or discharge day(one earlier).

Secondary Outcome Measures

Blood creatinine changes in renal function. [7 days]
Blood creatinine changes in renal function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.