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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 1, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with cardiaovascular death after 5-year follow up
    • Time Frame: 5 years
    • The cardiovascular mortality after 5-year follow up will be assessed to detect prognostic values of circulating biomarkers
  • Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
    • Time Frame: 5 years
    • New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea.

Secondary Measures

  • Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure
    • Time Frame: 1 year
    • 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.
  • Change From Baseline in left ventricular ejection fraction
    • Time Frame: 5 years
    • Assess the change in left ventricular ejection fraction at the end of 5-year follow up.
  • Change From Baseline in left ventricular end-systolic volume
    • Time Frame: 5 years
    • Assess the change in left ventricular end-systolic volume at the end of 5-year follow up.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shanghai 10th People’s Hospital
  • Collaborator
    • Tongji Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ya-Wei Xu, Professor – Shanghai 10th People’s Hospital
  • Overall Official(s)
    • Dachun Xu, Ph.D, Principal Investigator, Shanghai 10th People’s Hospital
  • Overall Contact(s)
    • Dachun Xu, Ph.D, 0086-18917684045, xdc77@tongji.edu.cn

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