Clinical trial NCT03727828: Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure
Official title: Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Nanfang Hospital, Southern Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yangpu Hospital
name: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Huashan Hospital Baoshan Branch
name: Shanghai Zhongye Hospital
name: Shanghai BaoshanLuodianHospital
name: Shanghai Shibei Hospital
name: Nantong Sixth People's Hospital
First posted: 2018-11-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with heart failure.Patients presenting with shortness of breathor edema and with increased NT-proBNP.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with cardiaovascular death after 5-year follow up
timeFrame: 5 years
measure: Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure
timeFrame: 1 year
measure: Change From Baseline in left ventricular ejection fraction
timeFrame: 5 years
measure: Change From Baseline in left ventricular end-systolic volume
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tongji University
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Dachun Xu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.