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

Primary Purpose

Pulmonary Arterial Hypertension, Randomized Controlled Trial

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tolvaptan
Furosemide
Sponsored by
Chinese Pulmonary Vascular Disease Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary arterial hypertension, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • center of pulmonary vascular disease, Fuwai hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subjects in group A

Subjects in group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Blood creatinine changes in renal function.
Blood creatinine changes in renal function.

Full Information

First Posted
October 1, 2022
Last Updated
October 4, 2022
Sponsor
Chinese Pulmonary Vascular Disease Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT05569655
Brief Title
Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH
Official Title
Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese Pulmonary Vascular Disease Research Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Randomized Controlled Trial
Keywords
Pulmonary arterial hypertension, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects in group A
Arm Type
Experimental
Arm Description
For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d).
Arm Title
Subjects in group B
Arm Type
Active Comparator
Arm Description
Subjects in group B receive standard therapy (including furosemide: 20mg-40mg/d).
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Other Intervention Name(s)
Samsca
Intervention Description
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
Intervention Name(s)
Furosemide
Other Intervention Name(s)
LASⅨ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in body weight( in kilograms ) of 7 days after medication or discharge day(one earlier).
Description
Changes in body weight ( in kilograms ) of 7 days after medication or discharge day(one earlier).
Time Frame
7 days
Title
Changes in urine volume (in milliliters）of 7 days after medication or discharge day(one earlier).
Description
Changes in urine volume ( in milliliters ) of 7 days after medication or discharge day(one earlier).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Blood creatinine changes in renal function.
Description
Blood creatinine changes in renal function.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihong Liu
Phone
+861088396590
Email
zhihongliufuwai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, MD#PhD
Organizational Affiliation
center of pulmonary vascular disease, Fuwai hospital
Official's Role
Study Director
Facility Information:
Facility Name
center of pulmonary vascular disease, Fuwai hospital
City
Beijing
ZIP/Postal Code
100041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, MD,PhD
Phone
+861088396590
Email
zhihongliufuwai@163.com
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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