COPDNCT03185572
Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension in China
An observational study of COPD and Pulmonary Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD and pulmonary hypertension may have pathological or genetics interactions so that patients having both disorders tend to have poor… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD, Pulmonary Hypertension
- How many people
- 1,708 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 31 Dec 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable COPD patients
Who may be able to join
- Stable chronic obstructive pulmonary disease (COPD) patients
Who cannot join
- Patients with other serious respiratory diseases
- Patients with pulmonary hypertension other than group 3
- Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
- Patients with limited life expectancy
- Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
- Psychopath or addict
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Guohua, Zhen, 13517277794, guohuazhen@hotmail.com
About this study
Official title: The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension
Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD and pulmonary hypertension may have pathological or genetics interactions so that patients having both disorders tend to have poor prognosis. Echocardiography is widely used to detect pulmonary hypertension, but it's not accurate enough. Therefore, high-quality data reflecting the prevalence, disease course and outcome of pulmonary hypertension in COPD is very limited in China. The aim of the study is to detect pulmonary hypertension with right heart catheterization, describe its outcome in Chinese COPD patients and explore the underlying interaction mechanism.
- Conditions
- COPD, Pulmonary Hypertension
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD exacerbations
total hospitalizations times due to COPD exacerbations
Measured: 3 years
Secondary outcomes (4)
modified British medical research council (mMRC) score
COPD symptom score
Measured: 3 years
COPD Assessment Test (CAT) score
COPD symptom score
Measured: 3 years
6 minutes walk distance
meters
Measured: 3 years
transplant-free survival rate
transplant-free survival rate in %
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- 1,708 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185572
- Sponsor's protocol ID
- 2016YFC1304401A
- Status last verified
- Jun 2017
- First submitted
- 10 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03185572
- Acronym / sponsor ID
- 2016YFC1304401A
- Conditions
- COPD, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,708 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (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.
Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD and pulmonary hypertension may have pathological or genetics interactions so that patients having both disorders tend to have poor prognosis. Echocardiography is widely used to detect pulmonary hypertension, but it's not accurate enough. Therefore, high-quality data reflecting the prevalence, disease course and outcome of pulmonary hypertension in COPD is very limited in China. The aim of the study is to detect pulmonary hypertension with right heart catheterization, describe its outcome in Chinese COPD patients and explore the underlying interaction mechanism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable COPD patients
Key inclusion criteria (1 listed)
- Stable chronic obstructive pulmonary disease (COPD) patients
Key exclusion criteria (6 listed)
- Patients with other serious respiratory diseases
- Patients with pulmonary hypertension other than group 3
- Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
- Patients with limited life expectancy
- Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
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
COPD exacerbations
Time frame: 3 years
total hospitalizations times due to COPD exacerbations
4 secondary outcomes
modified British medical research council (mMRC) score
Time frame: 3 years
COPD Assessment Test (CAT) score
Time frame: 3 years
6 minutes walk distance
Time frame: 3 years
transplant-free survival rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 COPD and Pulmonary Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 1 inclusion and 6 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 14 Jun 2017. 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 Guohua Zhen, MD (13517277794, guohuazhen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD exacerbations (time frame: 3 years). 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 14 Jun 2017.