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Clinical Trials/NCT02776384
NCT02776384
Recruiting
Not Applicable

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

Shanghai Jiao Tong University School of Medicine1 site in 1 country1,000 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
1000
Locations
1
Primary Endpoint
cardiovascular mortality
Status
Recruiting
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
December 2025
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Zhang Qi, MD

MD

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

cardiovascular mortality

Time Frame: 10 years

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

Secondary Outcomes

  • new stroke(10 years)
  • heart failure rehospitalization(10 years)
  • quality of life(10 years)
  • worsening of renal function(10 years)
  • all-cause mortality(10 years)
  • new myocardial infarction(10 years)

Study Sites (1)

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