Cardiovascular DiseasesBIOMS-HVDNCT06223906
A Registry Study of Biomarkers in Heart Valve Disease
An observational study of Cardiovascular Diseases, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
Valvular Heart Disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. The primary conditions within this category are Aortic Stenosis and Mitral Regurgitation. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 1 Jan 2030
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with heart valve disease accorrding to Inclusion and exclusion criteria.
Who may be able to join
- Patients clinically diagnosed with heart valve disease in Beijing Anzhen Hospital
Who cannot join
- Age < 18 years
- Failure to obtain medical records and ultrasound data
- Refuse follow-up
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
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yuan Wang, PhD, 86-010-64456169, wangyuan980510@163.com
Jie Du, PhD
About this study
Valvular Heart Disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. The primary conditions within this category are Aortic Stenosis and Mitral Regurgitation. These conditions are linked to considerable morbidity and mortality, presenting a formidable challenge in optimizing treatment strategies. Pathophysiology of Valvular Heart Disease remains poorly known. The aim of the present study is to identify biomarkers involved in this disease using multi-omics approaches
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
whether recidivation happened,whether other related disease happened
Measured: These data is collected during follow-up visit at 12 months after discharge
Secondary outcomes (1)
HF rehospitalization
heart failure related hospitalization within 1 years of discharge
Measured: These data is collected during follow-up visit at 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Jan 2016
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Du, Dr, Study director, The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223906
- Sponsor's protocol ID
- BIOMS-HVD
- Acronym
- BIOMS-HVD
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Biomarkers in Heart Valve Disease
- ClinicalTrials.gov ID
- NCT06223906
- Acronym / sponsor ID
- BIOMS-HVD / BIOMS-HVD
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 25 Jan 2024 (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.
Valvular Heart Disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. The primary conditions within this category are Aortic Stenosis and Mitral Regurgitation. These conditions are linked to considerable morbidity and mortality, presenting a formidable challenge in optimizing treatment strategies. Pathophysiology of Valvular Heart Disease remains poorly known. The aim of the present study is to identify biomarkers involved in this disease using multi-omics approaches
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart valve disease accorrding to Inclusion and exclusion criteria.
Key inclusion criteria (1 listed)
- Patients clinically diagnosed with heart valve disease in Beijing Anzhen Hospital
Key exclusion criteria (3 listed)
- Age < 18 years
- Failure to obtain medical records and ultrasound data
- Refuse follow-up
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 death
Time frame: These data is collected during follow-up visit at 12 months after discharge
whether recidivation happened,whether other related disease happened
1 secondary outcome
HF rehospitalization
Time frame: These data is collected during follow-up visit at 12 months after discharge
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 26 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.
Jie Du, Dr study director
The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
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 Cardiovascular Diseases, run by Beijing Institute of Heart, Lung and Blood Vessel 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 1 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 26 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 Yuan Wang, Dr (13910161443, wangyuan980510@163.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: These data is collected during follow-up visit at 12 months after discharge). 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 26 Jan 2024.