COPDNCT03184727
Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
An observational study of COPD and Pulmonary Vascular Disorder, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Pulmonary Vascular Disorder, Right Ventricular Dysfunction
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 31 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: stable COPD patients
Who may be able to join
- stable COPD patients
Who cannot join
- patents with other respiratory diseases and pulmonary hypertension other than group 3 PH;
- psychopath, addict or patients not able to coordinate;
- patients in pregnancy or breastfeeding;
- patients with limited life expectancy;
- patients with contraindiction for MRI or PET;
- patients having cerebrovascular events in 3 months;
- unstable COPD patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiovascular Institute and Fu Wai Hospital
Beijing, Beijing Municipality, 100037
Jianguo He, MD, 86 01088398060, hejianguofw@163.com
Jianguo He, MD
About this study
The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied. The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Ventricular Dysfunction, Right
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
survival rate in %
Measured: 3 years
Secondary outcomes (3)
COPD exacerbations
total times
Measured: 3 year
GOLD degree
Ⅰ-Ⅳ according to the pulmonary function
Measured: 3 year
NYHA degree
Ⅰ-Ⅳ according to the symptom
Measured: 3 year
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.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- 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
- NCT03184727
- Sponsor's protocol ID
- 2016YFC1304405
- Status last verified
- Jun 2017
- First submitted
- 8 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
- Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
- ClinicalTrials.gov ID
- NCT03184727
- Acronym / sponsor ID
- 2016YFC1304405
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 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.
The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied. The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- stable COPD patients
Key inclusion criteria (1 listed)
- stable COPD patients
Key exclusion criteria (7 listed)
- patents with other respiratory diseases and pulmonary hypertension other than group 3 PH;
- psychopath, addict or patients not able to coordinate;
- patients in pregnancy or breastfeeding;
- patients with limited life expectancy;
- patients with contraindiction for MRI or PET;
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
All-cause mortality
Time frame: 3 years
survival rate in %
3 secondary outcomes
COPD exacerbations
Time frame: 3 year
GOLD degree
Time frame: 3 year
NYHA degree
Time frame: 3 year
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 Vascular Disorder, 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 7 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 Jianguo He He, MD (80-10-88398060, hejianguofw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (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.