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

• Conditions: Heart Failure
• Interventions: Diagnostic Test: Patients with heart failure

• Registration Number: NCT03727828
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study First Submitted: 2018-10-21
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Study Start: 2018-11-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09
• Primary Completion: 2020-12-01
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with heart failure	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with cardiaovascular death after 5-year follow up	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital, Tongji University; 🇨🇳 Shanghai, Shanghai, China