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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569655
• Other study ID #: Tolvaptan
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: Chinese Pulmonary Vascular Disease Research Group
• Contact: Zhihong Liu
• Phone: +861088396590
• Email: zhihongliufuwai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension
• Randomized Controlled Trial

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	center of pulmonary vascular disease, Fuwai hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Blood creatinine changes in renal function.	Blood creatinine changes in renal function.	7 days