Heart Valve DiseasesNCT02865798
China Senile Valvular Heart Disease Cohort Study
An observational study of Heart Valve Diseases, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Valve Diseases
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In 71 hospitals have capable of valvular surgery in China, 4000 hospitalized patients over 60 years old with valvular heart disease will be enrolled consecutively.
Who may be able to join
- Hospitalized patients over 60 years old meet one of the following conditions.
- moderate or above valvular heart disease as defined by echocardiography:
- aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg,
- aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
- mitral stenosis, moderate or above, or valve area ≤2.0cm2,
- mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
Show all 12Show fewer
- tricuspid stenosis, moderate or above, or valve area ≤1.0cm2,
- tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2,
- pulmonic stenosis, moderate or above, or maximal jet velocity >4m/sec,
- pulmonic regurgitation, moderate or above,
- or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
- or diagnosis of endocarditis as assessed by Duke criteria.
Who cannot join
- Patients cannot be followed up for any reasons.
- Patients in critical condition may be die in the near future.
- Patients have been enrolled in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai hospital
Beijing, Beijing Municipality, 100037
Yongjian Wu, M.D, Ph.D, 0086-10-88396780, fuwaihospital@hotmail.com
Yongjian Wu, M.D., Ph.D.
About this study
Official title: Multicenter Prospective Cohort Study of Senile Hospitalized Patients With Valvular Heart Disease
Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.
- Conditions
- Heart Valve Diseases
- Keywords
- Heart Valve Diseases, Cardiovascular Diseases, Heart Disease, Valvular Heart Diseases
- Medical subject headings
- Heart Valve Diseases, Cardiovascular Diseases, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865798
- Sponsor's protocol ID
- VHD-20160805
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
Publications
Zhao Q, Xu H, Liu Q, Ye Y, Zhang B, Li Z, Gao R, Wu Y. Therapeutic Decision-Making and Outcomes in Elderly Patients With Severe Symptomatic Aortic Stenosis: Prognostic Implications of Elderly Patients' Initial Decisions. Front Cardiovasc Med. 2021 Jul 26;8:696763. doi: 10.3389/fcvm.2021.696763. eCollection 2021.
PubMed 34381825
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Study of Senile Hospitalized Patients With Valvular Heart Disease
- ClinicalTrials.gov ID
- NCT02865798
- Acronym / sponsor ID
- VHD-20160805
- Conditions
- Heart Valve Diseases
- Keywords
- Heart Valve Diseases, Cardiovascular Diseases, Heart Disease, Valvular Heart Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Aug 2016 (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.
Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In 71 hospitals have capable of valvular surgery in China, 4000 hospitalized patients over 60 years old with valvular heart disease will be enrolled consecutively.
Key inclusion criteria (12 listed)
- Hospitalized patients over 60 years old meet one of the following conditions.
- moderate or above valvular heart disease as defined by echocardiography:
- or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
- or diagnosis of endocarditis as assessed by Duke criteria.
Key exclusion criteria (3 listed)
- Patients cannot be followed up for any reasons.
- Patients in critical condition may be die in the near future.
- Patients have been enrolled in this study.
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: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Derived from this study: PubMed 34381825Zhao Q, Xu H, Liu Q, Ye Y, Zhang B, Li Z, Gao R, Wu Y. Therapeutic Decision-Making and Outcomes in Elderly Patients With Severe Symptomatic Aortic Stenosis: Prognostic Implications of Elderly Patients' Initial Decisions. Front Cardiovasc Med. 2021 Jul 26;8:696763. doi: 10.3389/fcvm.2021.696763. eCollection 2021.
Related trials for Heart Valve Diseases
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
Active, not recruiting
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
RecruitingObservational study
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
Mitral Valve Insufficiency
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
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 Heart Valve Diseases, run by China National Center for Cardiovascular Diseases 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 12 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: status not confirmed, as of the sponsor's last update on 12 Aug 2016. 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 Yongjian Wu, M.D., Ph.D. (0086-10-88396780, fuwaihospital@hotmail.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: one year). 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 NCT02865798, which also lists 1 linked publication.
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 12 Aug 2016.