Pulmonary HypertensionNCT06135909
CHASE Registry of Patients With Pulmonary Hypertension Receiving Targeted Therapy
An observational study of Pulmonary Hypertension, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
Trial summary
CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy (CHASE Study) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary hypertension receiving targeted therapy
Who may be able to join
- Sign informed consent;
- Between the ages of 18 and 85;
- Clinical diagnosis of pulmonary hypertension, using or planning to use pulmonary hypertension targeted drugs (including any one or more of the following: prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase agonists and prostacyclin receptor agonists).
Who cannot join
- Have a history of mental illness or drug or poison addiction, and can not sign informed consent or can not cooperate with the experimental study;
- Patients with malignant tumor and other diseases and life expectancy of less than half a year;
- Short-term (less than 2 weeks) patients taking targeted drugs for pulmonary hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC
Beijing, 100037
Zhihong Liu, MD,PhD, +861088396590, zhihongliufuwai@163.com
Zhihong Liu, MD,PhD
About this study
Official title: CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy
CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy (CHASE Study)
Read the detailed description
The purpose of this study was to establish the clinical characteristics and treatment strategies of targeted pulmonary hypertension patients in China: a multicenter, prospective case registry (CHASE) study to describe the clinical characteristics, treatment used, disease progression, and outcomes (e.g., death, hospitalization) of patients taking targeted drugs in real-world clinical practice. This study will collect high-quality real-world data that can be used as a standalone dataset or combined with other data sources to address critical issues in the PH field.
This is a prospective, observational, multicenter study. The expected number of enrolled cases for the entire study: at least 5000; No experimental group and control group were divided. Patients were followed up every 6 months ±2 weeks after enrollment for 3 years. The study selected patients who signed informed consent, aged 18-25 years, clinically diagnosed with pulmonary hypertension, and were applying or planning to apply targeted drugs for pulmonary hypertension as the study objects. The primary endpoint was the incidence of clinical exacerbations at 1 year after enrollment. Secondary endpoints were all-cause mortality at 1, 2, and 3 years after enrollment, rate of lung transplantation or combined cardiopulmonary transplantation, 6-minute walking distance, NT-proBNP level, WHO cardiac function grade, ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter, pulmonary hypertension targeted drug regimen, and incidence of associated adverse reactions.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PH Patients receiving targeted drugs treatment | Patients with pulmonary hypertension receiving targeted drugs treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical worsening events 1 year after enrollment
All-cause death, Pulmonary hypertension progression associated with re-hospitalization, Progress of pulmonary hypertension disease
Measured: 1 year after enrollment
Secondary outcomes (1)
Incidence of all-cause death 1,3,5 year(s) after enrollment
Incidence of all-cause death 1,3,5 year(s) after enrollment
Measured: 1,3,5 year(s) after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihong Liu, M.D., Ph.D, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135909
- Sponsor's protocol ID
- CHASE
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy
- ClinicalTrials.gov ID
- NCT06135909
- Acronym / sponsor ID
- CHASE
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Nov 2023 (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.
CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy (CHASE Study)
Detailed description
The purpose of this study was to establish the clinical characteristics and treatment strategies of targeted pulmonary hypertension patients in China: a multicenter, prospective case registry (CHASE) study to describe the clinical characteristics, treatment used, disease progression, and outcomes (e.g., death, hospitalization) of patients taking targeted drugs in real-world clinical practice. This study will collect high-quality real-world data that can be used as a standalone dataset or combined with other data sources to address critical issues in the PH field.
This is a prospective, observational, multicenter study. The expected number of enrolled cases for the entire study: at least 5000; No experimental group and control group were divided. Patients were followed up every 6 months ±2 weeks after enrollment for 3 years. The study selected patients who signed informed consent, aged 18-25 years, clinically diagnosed with pulmonary hypertension, and were applying or planning to apply targeted drugs for pulmonary hypertension as the study objects. The primary endpoint was the incidence of clinical exacerbations at 1 year after enrollment. Secondary endpoints were all-cause mortality at 1, 2, and 3 years after enrollment, rate of lung transplantation or combined cardiopulmonary transplantation, 6-minute walking distance, NT-proBNP level, WHO cardiac function grade, ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter, pulmonary hypertension targeted drug regimen, and incidence of associated adverse reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PH Patients receiving targeted drugs treatment | – | –Patients with pulmonary hypertension receiving targeted drugs treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary hypertension receiving targeted therapy
Key inclusion criteria (3 listed)
- Sign informed consent;
- Between the ages of 18 and 85;
- Clinical diagnosis of pulmonary hypertension, using or planning to use pulmonary hypertension targeted drugs (including any one or more of the following: prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase agonists and prostacyclin receptor agonists).
Key exclusion criteria (3 listed)
- Have a history of mental illness or drug or poison addiction, and can not sign informed consent or can not cooperate with the experimental study;
- Patients with malignant tumor and other diseases and life expectancy of less than half a year;
- Short-term (less than 2 weeks) patients taking targeted drugs for pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of clinical worsening events 1 year after enrollment
Time frame: 1 year after enrollment
All-cause death, Pulmonary hypertension progression associated with re-hospitalization, Progress of pulmonary hypertension disease
1 secondary outcome
Incidence of all-cause death 1,3,5 year(s) after enrollment
Time frame: 1,3,5 year(s) after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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.
Zhihong Liu, M.D., Ph.D principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, 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 3 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: looking for participants now, as of the sponsor's last update on 18 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Liu, M.D., Ph.D (8601088396816, zhihongliufuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical worsening events 1 year after enrollment (time frame: 1 year after enrollment). 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 18 Jan 2024.