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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Patients with heart failure

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth people's hospital, Tongji university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with heart failure.Patients presenting with shortness of breathor edema and with increased NT-proBNP.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy control
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.	Diagnostic test: Patients with heart failure; Participants will have serial blood collection on medical therapy for heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	5 years

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Tongji Hospital; Nanfang Hospital of Southern Medical University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Shanghai Zhongye Hospital; Shanghai Municipal Hospital of Traditional Chinese Medicine; Fuwai Hospital; Yangpu Hospital; Huashan Hospital Baoshan Branch; Shanghai BaoshanLuodianHospital; Shanghai Shibei Hospital; Nantong Sixth People's Hospital
• Investigators: Principal Investigator: Dachun Xu, Ph.D, Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: October 21, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DRAGON-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be available with reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No