Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure
1 other identifier
observational
3,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedJanuary 9, 2020
January 1, 2020
2 years
October 21, 2018
January 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
5 years
Secondary Outcomes (3)
Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure
1 year
Change From Baseline in left ventricular ejection fraction
5 years
Change From Baseline in left ventricular end-systolic volume
5 years
Study Arms (2)
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.
healthy control
Interventions
Participants will have serial blood collection on medical therapy for heart failure
Eligibility Criteria
Patients with heart failure.Patients presenting with shortness of breathor edema and with increased NT-proBNP.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai 10th People's Hospitallead
- Tongji Hospitalcollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Chinese Academy of Medical Sciences, Fuwai Hospitalcollaborator
- Yangpu Hospitalcollaborator
- Shanghai Municipal Hospital of Traditional Chinese Medicinecollaborator
- Huashan Hospital Baoshan Branchcollaborator
- Shanghai Zhongye Hospitalcollaborator
- Shanghai BaoshanLuodianHospitalcollaborator
- Shanghai Shibei Hospitalcollaborator
- Nantong Sixth People's Hospitalcollaborator
Study Sites (1)
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, 200072, China
Related Publications (3)
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.
PMID: 39267042DERIVEDMa 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.
PMID: 36635690DERIVEDSu 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.
PMID: 34612058DERIVED
Biospecimen
Peripheral blood collected at various time points according to the study cohort.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dachun Xu, Ph.D
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 21, 2018
First Posted
November 1, 2018
Study Start
November 15, 2018
Primary Completion
December 1, 2020
Study Completion
February 28, 2021
Last Updated
January 9, 2020
Record last verified: 2020-01