Heart FailureNCT03727828
Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure
An observational study of Heart Failure, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Patients with heart failure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2018to 28 Feb 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with heart failure.Patients presenting with shortness of breathor edema and with increased NT-proBNP.
Who may be able to join
- Age > 18 years of age
- Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
- Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment
Who cannot join
- Life expectancy <1 year due to causes other than HF such as advanced cancer
- Cardiac transplantation or revascularization indicated or expected within 6 months
- Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)
- Subject unable or unwilling to provide written informed consent
- Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
- Progressive neurological disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, 200072
Dachun Xu, MD,PhD, +86 18917684045, xdc77@tongji.edu.cn
Yawei Xu, MD,PhD, +86 13916698181, xuyawei@tongji.edu.cn
About this study
Official title: Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study
The objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.
Read the detailed description
Blood samples (plasma or serum) for heart failure patients presenting dyspnea or edema and with increased NT-proBNP. The objective of this work is to investigate and then to sequence new proteins or microRNAs in the blood of these patients for diagnostic, risk stratification and prognostic purpose.
- Conditions
- Heart Failure
- Being tested
- Patients with heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with heart failureDiagnostic test
Participants will have serial blood collection on medical therapy for heart failure
| Study group | Role | What they receive |
|---|---|---|
| Patients with heart failure | Patients with heart failure (HF) who are followed in the hospital or clinic setting, with optimization of medical therapy and blood collection. Receives: Diagnostic Test: Patients with heart failure | |
| healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cardiaovascular death after 5-year follow up
The cardiovascular mortality after 5-year follow up will be assessed to detect prognostic values of circulating biomarkers
Measured: 5 years
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea.
Measured: 5 years
Secondary outcomes (3)
Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure
Compare the sensitivity and specificity of new biomarker with NT-ProBNP to assess the accuracy of diagnostic value in discriminating heart failure from non-heart failure participants.
Measured: 1 year
Change From Baseline in left ventricular ejection fraction
Assess the change in left ventricular ejection fraction at the end of 5-year follow up.
Measured: 5 years
Change From Baseline in left ventricular end-systolic volume
Assess the change in left ventricular end-systolic volume at the end of 5-year follow up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start15 Nov 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion28 Feb 2021 (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 Heart FailureStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, Yangpu Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Huashan Hospital, Shanghai Zhongye Hospital, Shanghai BaoshanLuodianHospital, Shanghai Shibei Hospital, Nantong Sixth People's Hospital
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Dachun Xu, Ph.D, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727828
- Sponsor's protocol ID
- DRAGON-HF
- Status last verified
- Jan 2020
- First submitted
- 21 Oct 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be available with reasonable request.
Publications
Wang Z, Zhu Z, Shen J, Zhang Y, Wang T, Xu Y, Jiang D, Liu W. Predictive value of remnant cholesterol for left ventricular hypertrophy and prognosis in hypertensive patients with heart failure: a prospective study. Lipids Health Dis. 2024 Sep 12;23(1):294. doi: 10.1186/s12944-024-02282-y.
PubMed 39267042Ma T, Huang R, Xu Y, Lv Y, Liu Y, Pan X, Dong J, Gao D, Wang Z, Zhang F, Yan C, Ong SB, Su Y, Xu D. Plasma GAS6 predicts mortality risk in acute heart failure patients: insights from the DRAGON-HF trial. J Transl Med. 2023 Jan 12;21(1):21. doi: 10.1186/s12967-022-03859-w.
PubMed 36635690Su Y, Sun Y, Tang Y, Li H, Wang X, Pan X, Liu W, Zhang X, Zhang F, Xu Y, Yan C, Ong SB, Xu D. Circulating miR-19b-3p as a Novel Prognostic Biomarker for Acute Heart Failure. J Am Heart Assoc. 2021 Oct 19;10(20):e022304. doi: 10.1161/JAHA.121.022304. Epub 2021 Oct 6.
PubMed 34612058
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study
- ClinicalTrials.gov ID
- NCT03727828
- Acronym / sponsor ID
- DRAGON-HF
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, Yangpu Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Huashan Hospital, Shanghai Zhongye Hospital, Shanghai BaoshanLuodianHospital, Shanghai Shibei Hospital, Nantong Sixth People's Hospital
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 1 Nov 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 objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.
Detailed description
Blood samples (plasma or serum) for heart failure patients presenting dyspnea or edema and with increased NT-proBNP. The objective of this work is to investigate and then to sequence new proteins or microRNAs in the blood of these patients for diagnostic, risk stratification and prognostic purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure | – | Diagnostic Test: Patients with heart failurePatients with heart failure (HF) who are followed in the hospital or clinic setting, with optimization of medical therapy and blood collection. |
| healthy control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure.Patients presenting with shortness of breathor edema and with increased NT-proBNP.
Key inclusion criteria (3 listed)
- Age > 18 years of age
- Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
- Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment
Key exclusion criteria (7 listed)
- Life expectancy <1 year due to causes other than HF such as advanced cancer
- Cardiac transplantation or revascularization indicated or expected within 6 months
- Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)
- Subject unable or unwilling to provide written informed consent
- Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
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 |
|---|---|---|
| Patients with heart failureParticipants will have serial blood collection on medical therapy for heart failure | Diagnostic test | Patients with heart failure |
Primary outcome
Number of participants with cardiaovascular death after 5-year follow up
Time frame: 5 years
The cardiovascular mortality after 5-year follow up will be assessed to detect prognostic values of circulating biomarkers
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
Time frame: 5 years
New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea.
3 secondary outcomes
Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure
Time frame: 1 year
Change From Baseline in left ventricular ejection fraction
Time frame: 5 years
Change From Baseline in left ventricular end-systolic volume
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 39267042Wang Z, Zhu Z, Shen J, Zhang Y, Wang T, Xu Y, Jiang D, Liu W. Predictive value of remnant cholesterol for left ventricular hypertrophy and prognosis in hypertensive patients with heart failure: a prospective study. Lipids Health Dis. 2024 Sep 12;23(1):294. doi: 10.1186/s12944-024-02282-y.
- Derived from this study: PubMed 36635690Ma T, Huang R, Xu Y, Lv Y, Liu Y, Pan X, Dong J, Gao D, Wang Z, Zhang F, Yan C, Ong SB, Su Y, Xu D. Plasma GAS6 predicts mortality risk in acute heart failure patients: insights from the DRAGON-HF trial. J Transl Med. 2023 Jan 12;21(1):21. doi: 10.1186/s12967-022-03859-w.
- Derived from this study: PubMed 34612058Su Y, Sun Y, Tang Y, Li H, Wang X, Pan X, Liu W, Zhang X, Zhang F, Xu Y, Yan C, Ong SB, Xu D. Circulating miR-19b-3p as a Novel Prognostic Biomarker for Acute Heart Failure. J Am Heart Assoc. 2021 Oct 19;10(20):e022304. doi: 10.1161/JAHA.121.022304. Epub 2021 Oct 6.
- Individual participant dataSharing planned: Undecided. IPD will be available with reasonable request.
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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.
Dachun Xu, Ph.D principal investigator
Shanghai 10th People's 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 Heart Failure, run by Shanghai 10th People's Hospital 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 3 inclusion and 7 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 9 Jan 2020. 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 Dachun Xu, Ph.D (0086-18917684045, xdc77@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with cardiaovascular death after 5-year follow up (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT03727828, 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 9 Jan 2020.