Cardiovascular DiseasesBIOMS-HFNCT03784833
A Registry Study of Biomarkers in Heart Failure
An observational study of Cardiovascular Diseases, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
The registry study aims to discover the prognostic value of bio-markers in heart failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with heart failure accorrding to Inclusion and exclusion criteria.
Who may be able to join
- Age greater than or equal to 18 years at the time of admission to the hospital
- With symptoms of new-onset or worsening heart failure
- Received or is eligible to receive a principal hospital discharge diagnosis of HF
- With signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
- Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;
Who cannot join
- Have objective evidence of cardiac dysfunction documented either by plasma concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) <35 pg/mL or <125 pg/ml, respectively
- Current known inability to follow instructions or comply with follow-up procedures.
- Eligible patients without informed consent form
Trial locations and contacts
1 site in 1 country.
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
The registry study aims to discover the prognostic value of bio-markers in heart failure
Read the detailed description
The purpose of this study is to investigate the prognostic value of biomarkers in Heart Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.
- Conditions
- Cardiovascular Diseases
- Keywords
- heart failure
- Medical subject headings
- Cardiovascular Diseases, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death (all cause)
Number of death within 2 years of discharge
Measured: 2 years of follow-up
Secondary outcomes (2)
Number of rehospitalizations for acute heart failure (HF)
Number of heart failure related hospitalization within 2 years of discharge
Measured: 2 years of follow-up
Number of death ( all cause) or readmission for heart failure
Number of Death or heart failure related hospitalization within 2 years of discharge
Measured: 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study startJun 2016
- Primary completionJun 2022 (estimated)
- Study completionJun 2024 (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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Second Hospital, Second Affiliated Hospital of Wenzhou Medical University, Beijing Luhe Hospital, China-Japan Friendship Hospital
- 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
- NCT03784833
- Sponsor's protocol ID
- BIOMS-HF
- Acronym
- BIOMS-HF
- Status last verified
- Apr 2019
- First submitted
- 20 Dec 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Biomarkers in Heart Failure
- ClinicalTrials.gov ID
- NCT03784833
- Acronym / sponsor ID
- BIOMS-HF / BIOMS-HF
- Conditions
- Cardiovascular Diseases
- Keywords
- heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Collaborators
- Tianjin Medical University Second Hospital, Second Affiliated Hospital of Wenzhou Medical University, Beijing Luhe Hospital, China-Japan Friendship Hospital
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 24 Dec 2018 (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 registry study aims to discover the prognostic value of bio-markers in heart failure
Detailed description
The purpose of this study is to investigate the prognostic value of biomarkers in Heart Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure accorrding to Inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years at the time of admission to the hospital
- With symptoms of new-onset or worsening heart failure
- Received or is eligible to receive a principal hospital discharge diagnosis of HF
- With signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
- Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;
Key exclusion criteria (3 listed)
- Have objective evidence of cardiac dysfunction documented either by plasma concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) <35 pg/mL or <125 pg/ml, respectively
- Current known inability to follow instructions or comply with follow-up procedures.
- Eligible patients without informed consent form
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
Number of death (all cause)
Time frame: 2 years of follow-up
Number of death within 2 years of discharge
2 secondary outcomes
Number of rehospitalizations for acute heart failure (HF)
Time frame: 2 years of follow-up
Number of death ( all cause) or readmission for heart failure
Time frame: 2 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
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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.
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 5 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 23 Apr 2019. 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 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?
Number of death (all cause) (time frame: 2 years of follow-up). 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 23 Apr 2019.