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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension; Randomized Controlled Trial
• Intervention / Treatment: Drug: Tolvaptan; Drug: Furosemide

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhihong Liu; Phone Number: +861088396590; Email: zhihongliufuwai@163.com

Study Locations

• China
  • Beijing, China, 100041
    • Recruiting
    • Center of pulmonary vascular disease, Fuwai hospital
    • Principal Investigator: Zhihong Liu, MD,PhD
    • Contact: Zhihong Liu, MD,PhD; Phone Number: +861088396590; Email: zhihongliufuwai@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood creatinine changes in renal function.	Blood creatinine changes in renal function.	7 days

Collaborators and Investigators

• Sponsor: Chinese Pulmonary Vascular Disease Research Group
• Investigators: Study Director: Zhihong Liu, MD#PhD, Center of pulmonary vascular disease, Fuwai hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Pulmonary arterial hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Antidiuretic Hormone Receptor Antagonists; Furosemide; Tolvaptan
• Other Study ID Numbers: Tolvaptan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No