CClinicalTrials.gg
Status unknownNCT03727828Updated Jan 9, 2020

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

An observational study in Heart Failure, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by Shanghai 10th People's Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

Browse trials for

03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

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.

    Diagnostic Test: Patients with heart failure

  • healthy control

Interventions

  • Diagnostic testPatients with heart failure

    Participants will have serial blood collection on medical therapy for heart failure

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

  2. 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.

    Time frame: 5 years

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. Change From Baseline in left ventricular ejection fraction

    Assess the change in left ventricular ejection fraction at the end of 5-year follow up.

    Time frame: 5 years

  3. 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.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai Tenth People's Hospital, Tongji University
    Shanghai, Shanghai 200072, China
    Recruiting
08

References and documents

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. PubMed 34612058 ↗

Individual participant data

Plan to share: Undecided — IPD will be available with reasonable request.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03727828
Lead sponsor
Shanghai 10th People's Hospital
Collaborators
Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, Yangpu Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Huashan Hospital Baoshan Branch, Shanghai Zhongye Hospital, Shanghai BaoshanLuodianHospital, Shanghai Shibei Hospital, Nantong Sixth People's Hospital
Responsible party
Ya-Wei Xu (Professor, Shanghai 10th People's Hospital) — Principal investigator
First posted
Nov 1, 2018
Start date
Nov 15, 2018
Primary completion
Dec 1, 2020 (estimated)
Completion
Feb 28, 2021 (estimated)
Last update
Jan 9, 2020

Study contacts

Dachun Xu, Ph.D
Contact
xdc77@tongji.edu.cn
0086-18917684045
Yuxi Sun, Ph.D
Contact
sunyuxitj10h@163.com
0086-15216718171
Dachun Xu, Ph.D
principal investigator · Shanghai 10th People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion