Pulmonary Hypertension Due to Left Heart DiseaseNCT02164526
Registry for Pulmonary Hypertension Due to Left Heart Disease in China
An observational study of Pulmonary Hypertension Due to Left Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites in China.
Trial summary
Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension Due to Left Heart Disease
- What is being tested?
- Routine therapy
- How many people
- 520 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2013to Dec 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who were diagnosed as pulmonary hypertension due to the left heart disease in 35 participating institutions in China
Who may be able to join
- Pulmonary Hypertension due to left heart disease
Who cannot join
- Other forms of Pulmonary Hypertension
- Heart failure due to valvular heart disease
- Hypertrophic obstructive cardiomyopathy
- Right ventricular outflow tract stenosis
- Pericardial disease
- Patients with chronic lung disease
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
861088398294
Jianguo He, MD. Ph.D
- Recruiting
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Tao Yang, MD, 861088396509, tsmcyt@163.com
Jianguo He, MD.Ph.D
About this study
Official title: National, Prospective, Multicenter,Observational Registry Study on Pulmonary Hypertension Due to Left Heart Disease in China
Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. However, there is no research on the prevalence of pulmonary hypertension due to the left heart disease in China. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary hypertension due to the left heart disease and identify factors that may predict outcome. Our study will profile the demographics, clinical course, treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.
- Being tested
- Routine therapy
- Keywords
- Pulmonary Hypertension, Left Heart Disease, Heart failure, Registry, China
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine therapyOther
Routine therapy
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described Receives: Other: Routine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause death
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Hypertension Due to Left Heart DiseaseStudies 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
- 520 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
- NCT02164526
- Sponsor's protocol ID
- CRPHDLHD
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2014
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang L, Pang L, Gu Q, Yang T, Li W, Quan R, Su W, Wu W, Tang F, Zhu X, Shen J, Sun J, Shan G, Xiong C, Huang S, He J. Prevalence, risk factors, and survival associated with pulmonary hypertension and heart failure among patients with underlying coronary artery disease: a national prospective, multicenter registry study in China. Chin Med J (Engl). 2022 Aug 5;135(15):1837-1845. doi: 10.1097/CM9.0000000000002112.
PubMed 36195993Lin Y, Pang L, Huang S, Shen J, Wu W, Tang F, Su W, Zhu X, Sun J, Quan R, Yang T, Han H, He J. Impact of borderline pulmonary hypertension due to left heart failure on mortality in a multicenter registry study: A 3-year survivorship analysis. Front Cardiovasc Med. 2022 Aug 12;9:983803. doi: 10.3389/fcvm.2022.983803. eCollection 2022.
PubMed 36035936Quan R, Huang S, Pang L, Shen J, Wu W, Tang F, Zhu X, Su W, Sun J, Yu Z, Wang L, Zhu X, Xiong C, He J. Risk prediction in pulmonary hypertension due to chronic heart failure: incremental prognostic value of pulmonary hemodynamics. BMC Cardiovasc Disord. 2022 Feb 16;22(1):56. doi: 10.1186/s12872-022-02492-1.
PubMed 35172722
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
- National, Prospective, Multicenter,Observational Registry Study on Pulmonary Hypertension Due to Left Heart Disease in China
- ClinicalTrials.gov ID
- NCT02164526
- Acronym / sponsor ID
- CRPHDLHD
- Keywords
- Pulmonary Hypertension, Left Heart Disease, Heart failure, Registry, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Jun 2014 (estimated)
- 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.
Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. However, there is no research on the prevalence of pulmonary hypertension due to the left heart disease in China. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary hypertension due to the left heart disease and identify factors that may predict outcome. Our study will profile the demographics, clinical course, treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: Routine therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who were diagnosed as pulmonary hypertension due to the left heart disease in 35 participating institutions in China
Key inclusion criteria (1 listed)
- Pulmonary Hypertension due to left heart disease
Key exclusion criteria (6 listed)
- Other forms of Pulmonary Hypertension
- Heart failure due to valvular heart disease
- Hypertrophic obstructive cardiomyopathy
- Right ventricular outflow tract stenosis
- Pericardial disease
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 |
|---|---|---|
| Routine therapyRoutine therapy | Other | No treatment |
Primary outcome
All cause death
Time frame: up to 5 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.
- Derived from this study: PubMed 36195993Huang L, Pang L, Gu Q, Yang T, Li W, Quan R, Su W, Wu W, Tang F, Zhu X, Shen J, Sun J, Shan G, Xiong C, Huang S, He J. Prevalence, risk factors, and survival associated with pulmonary hypertension and heart failure among patients with underlying coronary artery disease: a national prospective, multicenter registry study in China. Chin Med J (Engl). 2022 Aug 5;135(15):1837-1845. doi: 10.1097/CM9.0000000000002112.
- Derived from this study: PubMed 36035936Lin Y, Pang L, Huang S, Shen J, Wu W, Tang F, Su W, Zhu X, Sun J, Quan R, Yang T, Han H, He J. Impact of borderline pulmonary hypertension due to left heart failure on mortality in a multicenter registry study: A 3-year survivorship analysis. Front Cardiovasc Med. 2022 Aug 12;9:983803. doi: 10.3389/fcvm.2022.983803. eCollection 2022.
- Derived from this study: PubMed 35172722Quan R, Huang S, Pang L, Shen J, Wu W, Tang F, Zhu X, Su W, Sun J, Yu Z, Wang L, Zhu X, Xiong C, He J. Risk prediction in pulmonary hypertension due to chronic heart failure: incremental prognostic value of pulmonary hemodynamics. BMC Cardiovasc Disord. 2022 Feb 16;22(1):56. doi: 10.1186/s12872-022-02492-1.
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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.
2 sites 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 Due to Left Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites 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 2 sites 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, MD (861088398826, hejianguofw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02164526, which also lists 3 linked publications.
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.