Cardiovascular DiseasesNCT04108182
A Registry Study of Biomarkers in Progression of Acute Heart Failure(BIOMS-POAHF)
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 acute heart failure Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 850 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Oct 2025
- 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
- Adult, Older adult
Study population: Patients with heart failure accorrding to Inclusion and exclusion criteria
Who may be able to join
- 1. Patients aged greater than or equal to 18 years with acute exacerbation of chronic heart failure or new heart failure
- 2. With typical symptoms of acute heart failure as follows: Dyspnea, ankle swelling and fatigue (Limited activity endurance), increased jugular pressure, rales and peripheral edema ;
- 3. Plasma concentrations of BNP: BNP>100pg/ML
- 4. Echocardiography: Related structural heart disease (left ventricular hypertrophy and/or left atrial enlargement) and/or diastolic dysfunction
Who cannot join
- 1. Previous history of cancer or renal replacement therapy
- 2.Surgery was performed within a month
- 3.Accompanied by cardiogenic shock, sepsis, pneumonia
- 4.Eligible patients without informed consent form
Trial locations and contacts
1 site in 1 country.
Yulin Li, PHD contact
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, 100029
ke-xu Yang, 86-010-64426153, EC@anzhenGCP.com
About this study
Official title: A Registry Study of Biomarkers in Progression of Acute Heart Failure
The registry study aims to discover the prognostic value of bio-markers in acute heart failure
- 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) or readmission for heart failure
Number of Death or heart failure related hospitalization within a median follow-up of 8.8 months of discharge
Measured: a median follow-up of 8.8 months
Secondary outcomes (1)
Number of death ( all cause) or readmission for heart failure and cardiovascular mortality
Number of Death or heart failure related hospitalization and cardiovascular mortality within a median follow-up of 8.8 months of discharge
Measured: a median follow-up of 8.8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study startDec 2015
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (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 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
- Prospective
- Enrolment
- 850 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, PHD, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108182
- Sponsor's protocol ID
- BIOMS-POAHF
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma K, Yang J, Shao Y, Li P, Guo H, Wu J, Zhu Y, Zhang H, Zhang X, Du J, Li Y. Therapeutic and Prognostic Significance of Arachidonic Acid in Heart Failure. Circ Res. 2022 Apr;130(7):1056-1071. doi: 10.1161/CIRCRESAHA.121.320548. Epub 2022 Mar 8.
PubMed 35255710
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Biomarkers in Progression of Acute Heart Failure
- ClinicalTrials.gov ID
- NCT04108182
- Acronym / sponsor ID
- BIOMS-POAHF
- Conditions
- Cardiovascular Diseases
- Keywords
- heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 30 Sep 2019 (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 acute heart failure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure accorrding to Inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- 1. Patients aged greater than or equal to 18 years with acute exacerbation of chronic heart failure or new heart failure
- 2. With typical symptoms of acute heart failure as follows: Dyspnea, ankle swelling and fatigue (Limited activity endurance), increased jugular pressure, rales and peripheral edema ;
- 3. Plasma concentrations of BNP: BNP>100pg/ML
- 4. Echocardiography: Related structural heart disease (left ventricular hypertrophy and/or left atrial enlargement) and/or diastolic dysfunction
Key exclusion criteria (4 listed)
- 1. Previous history of cancer or renal replacement therapy
- 2.Surgery was performed within a month
- 3.Accompanied by cardiogenic shock, sepsis, pneumonia
- 4.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) or readmission for heart failure
Time frame: a median follow-up of 8.8 months
Number of Death or heart failure related hospitalization within a median follow-up of 8.8 months of discharge
1 secondary outcome
Number of death ( all cause) or readmission for heart failure and cardiovascular mortality
Time frame: a median follow-up of 8.8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 35255710Ma K, Yang J, Shao Y, Li P, Guo H, Wu J, Zhu Y, Zhang H, Zhang X, Du J, Li Y. Therapeutic and Prognostic Significance of Arachidonic Acid in Heart Failure. Circ Res. 2022 Apr;130(7):1056-1071. doi: 10.1161/CIRCRESAHA.121.320548. Epub 2022 Mar 8.
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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.
Yulin Li, PHD contact
Jie Du, PHD study director
Beijing Anzhen Hospital
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 4 inclusion and 4 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 30 Sep 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 Yulin Li, PHD (lyllyl_1111@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) or readmission for heart failure (time frame: a median follow-up of 8.8 months). 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 NCT04108182, 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 30 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.