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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05569655
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chinese Pulmonary Vascular Disease Research Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zhihong Liu, MD#PhD
Principal Investigator Affiliation center of pulmonary vascular disease, Fuwai hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, Randomized Controlled Trial
Additional Details

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.

Arms & Interventions

Arms

Experimental: Subjects in group A

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

Active Comparator: Subjects in group B

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

Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, China

Status

Recruiting

Address

center of pulmonary vascular disease, Fuwai hospital

Beijing, , 100041

Site Contact

Zhihong Liu, MD,PhD

zhihongliufuwai@163.com

+861088396590

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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