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RecruitingNCT02776384Updated May 18, 2016

Prognostic and Diagnostic Value of Biomarkers and Cardiac Functional Parameters in Patients With Chronic Heart Failure

An observational study in Chronic Heart Failure, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

The study aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The study also intends to describe comparison of echocardiography with cardiopulmonary function test in CHF patients, and relating these cardiac functional parameters to clinical outcome.

02

Conditions studied

  • Chronic Heart Failure

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Keywords

  • Heart Failure
  • Biomarkers
  • Echocardiography
  • Cardiopulmonary Function Tests
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 1,000 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 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
No
Sampling method
Non-probability sample

Study population

patients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction in NYHA Ⅱ\~Ⅳ

Inclusion criteria

  • Age ≥18 years
  • with symptoms and signs in NYHA Ⅱ\~Ⅳ
  • with cardiac structural changes confirmed by echocardiography

Exclusion criteria

Exclusion Criteria:

  • with other severe diseases combined and will be alive for less than 12 months
  • hard to participate in the investigation or accept the follow-up visits
  • pregnant or lactating women
  • during the acute phase of ST-elevation acute myocardial infarction, stroke, severe infection and other critical conditions
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • chronic heart failure

    patients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction

    Other: Observational study

Interventions

  • OtherObservational study

    Also known as: no intervention

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What researchers measure

Primary outcomes

  1. main adverse cardiovascular and cerebrovascular events, MACCE

    MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization

    Time frame: 10 years

  2. cardiovascular mortality

    Time frame: 10 years

Secondary outcomes

  1. all-cause mortality

    Time frame: 10 years

  2. new myocardial infarction

    Time frame: 10 years

  3. new stroke

    Time frame: 10 years

  4. heart failure rehospitalization

    Time frame: 10 years

  5. quality of life

    described in quality of life scores

    Time frame: 10 years

  6. worsening of renal function

    either an increase of 0.3 mg/dl in serum creatinine or a 20% decrease in eGFR compared with baseline

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200025, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02776384
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Zhang Qi, MD (MD, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
May 18, 2016
Start date
Dec 2015
Primary completion
Dec 2025 (estimated)
Last update
May 18, 2016

Study contacts

Rong Tao, Doctor
Contact
rongtao@hotmail.com

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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