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

Heart Failure Clinical Trial

Official title:

Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03727828
• Other study ID #: DRAGON-HF
• Status: Recruiting
• Start date: November 15, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2020
• Source: Shanghai 10th People's Hospital
• Contact: Dachun Xu, Ph.D
• Phone: 0086-18917684045
• Email: xdc77[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: February 28, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• Patients with heart failure
Participants will have serial blood collection on medical therapy for heart failure

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital, Tongji University	Shanghai	Shanghai

Sponsors (13)

Lead Sponsor

Collaborator

Shanghai 10th People's Hospital

First Affiliated Hospital, Sun Yat-Sen University, Fuwai Hospital, Huashan Hospital Baoshan Branch, Nanfang Hospital of Southern Medical University, Nantong Sixth People's Hospital, Shanghai BaoshanLuodianHospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Shibei Hospital, Shanghai Zhongye Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tongji Hospital, Yangpu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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