Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure

NCT ID: NCT03727828

Last Updated: 2020-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-02-28

Brief Summary

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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

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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

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Patients with heart failure

Intervention Type DIAGNOSTIC_TEST

Participants will have serial blood collection on medical therapy for heart failure

healthy control

No interventions assigned to this group

Interventions

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Patients with heart failure

Participants will have serial blood collection on medical therapy for heart failure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years of age
2. Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
3. Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion Criteria

1. Life expectancy \<1 year due to causes other than HF such as advanced cancer
2. Cardiac transplantation or revascularization indicated or expected within 6 months
3. Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec \<1 L (when diagnosed as standard of care)
4. Subject unable or unwilling to provide written informed consent
5. Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
6. Progressive neurological disease
7. Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Yangpu Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Municipal Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Huashan Hospital Baoshan Branch

UNKNOWN

Sponsor Role collaborator

Shanghai Zhongye Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai BaoshanLuodianHospital

UNKNOWN

Sponsor Role collaborator

Shanghai Shibei Hospital

UNKNOWN

Sponsor Role collaborator

Nantong Sixth People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dachun Xu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai Tenth People's Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dachun Xu, Ph.D

Role: CONTACT

0086-18917684045

Yuxi Sun, Ph.D

Role: CONTACT

0086-15216718171

Facility Contacts

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Dachun Xu, MD,PhD

Role: primary

+86 18917684045

Yawei Xu, MD,PhD

Role: backup

+86 13916698181

References

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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.

Reference Type DERIVED
PMID: 39267042 (View on PubMed)

Ma 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.

Reference Type DERIVED
PMID: 36635690 (View on PubMed)

Su 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.

Reference Type DERIVED
PMID: 34612058 (View on PubMed)

Other Identifiers

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DRAGON-HF

Identifier Type: -

Identifier Source: org_study_id

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