Pulmonary Arterial HypertensionNCT05569655
Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH
A study testing Tolvaptan and Furosemide in people with Pulmonary Arterial Hypertension and Randomized Controlled Trial, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
Trial summary
Efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension, Randomized Controlled Trial
- What is being tested?
- Tolvaptan and Furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
center of pulmonary vascular disease, Fuwai hospital
Beijing, 100041
Zhihong Liu, MD,PhD, +861088396590, zhihongliufuwai@163.com
Zhihong Liu, MD,PhD
About this study
Official title: 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
Read the 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.
- Being tested
- Tolvaptan, Furosemide
- Keywords
- Pulmonary arterial hypertension, Randomized controlled trial
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
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.
FurosemideDrug
Also called LASⅨ
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects in group A | Experimental | For subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d). Receives: Drug: Tolvaptan; Drug: Furosemide |
| Subjects in group B | Active comparator | Subjects in group B receive standard therapy (including furosemide: 20mg-40mg/d). Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 7 days
Secondary outcomes (1)
Blood creatinine changes in renal function.
Blood creatinine changes in renal function.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start6 Apr 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihong Liu, MD#PhD, Study director, center of pulmonary vascular disease, Fuwai hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569655
- Sponsor's protocol ID
- Tolvaptan
- Status last verified
- Sep 2022
- First submitted
- 1 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT05569655
- Acronym / sponsor ID
- Tolvaptan
- Keywords
- Pulmonary arterial hypertension, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects in group A | Experimental | Drug: Tolvaptan, Drug: FurosemideFor subjects in group A, tolvaptan (15 mg/d) is added to standard therapy (furosemide: 20mg-40mg/d). |
| Subjects in group B | Active comparator | Drug: FurosemideSubjects in group B receive standard therapy (including furosemide: 20mg-40mg/d). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolvaptanAlso: SamscaWithin 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 | Subjects in group A |
| FurosemideAlso: LASⅨWithin 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. | Drug | Subjects in group A, Subjects in group B |
Primary outcome
Changes in body weight( in kilograms ) of 7 days after medication or discharge day(one earlier).
Time frame: 7 days
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).
Time frame: 7 days
Changes in urine volume ( in milliliters ) of 7 days after medication or discharge day(one earlier).
1 secondary outcome
Blood creatinine changes in renal function.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhihong Liu, MD#PhD study director
center of pulmonary vascular disease, Fuwai hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tolvaptan and Furosemide in people with Pulmonary Arterial Hypertension and Randomized Controlled Trial, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Liu (+861088396590, zhihongliufuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight( in kilograms ) of 7 days after medication or discharge day(one earlier). (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.