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

May 15, 2016 updated by: Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine

Prognostic and Diagnostic Value of Serial Biomarker Measurements, Echocardiographic Techniques and Cardiopulmonary Function Tests in Patients With Chronic Heart Failure.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic heart failure
patients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction
Other: Observational study
Other Names:
  • no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
main adverse cardiovascular and cerebrovascular events, MACCE
Time Frame: 10 years
MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization
10 years
cardiovascular mortality
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 10 years
10 years
new myocardial infarction
Time Frame: 10 years
10 years
new stroke
Time Frame: 10 years
10 years
heart failure rehospitalization
Time Frame: 10 years
10 years
quality of life
Time Frame: 10 years
described in quality of life scores
10 years
worsening of renal function
Time Frame: 10 years
either an increase of 0.3 mg/dl in serum creatinine or a 20% decrease in eGFR compared with baseline
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 15, 2016

First Submitted That Met QC Criteria

May 15, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 15, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH-20151127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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