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

NCT05569655 | Unknown DMC

• 1 other identifier: Tolvaptan
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension; Randomized Controlled Trial

Keywords

Pulmonary arterial hypertension; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Blood creatinine changes in renal function.

  7 days

Study Arms (2)

Subjects in group A

EXPERIMENTAL

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

Drug: Tolvaptan; Drug: Furosemide

Subjects in group B

ACTIVE COMPARATOR

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

Drug: Furosemide

Interventions

Tolvaptan 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.

Also known as: Samsca

Subjects in group A

Furosemide 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.

Also known as: LASⅨ

Subjects in group A; Subjects in group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Additionally, patients who were judged by the investigators not fit to be enrolled in this trial.

Sponsors & Collaborators

• Chinese Pulmonary Vascular Disease Research Group: lead

Study Sites (1)

center of pulmonary vascular disease, Fuwai hospital

Beijing, 100041, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Tolvaptan; Furosemide

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Zhihong Liu, MD#PhD

  center of pulmonary vascular disease, Fuwai hospital

  STUDY DIRECTOR

Central Study Contacts

Zhihong Liu

CONTACT

+861088396590; zhihongliufuwai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 6, 2022
• Study Start: April 6, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)