NCT02776384

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

10 years

First QC Date

May 15, 2016

Last Update Submit

May 15, 2016

Conditions

Chronic Heart Failure

Keywords

Heart FailureBiomarkersEchocardiographyCardiopulmonary Function Tests

Outcome Measures

Primary Outcomes (2)

  • 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

    10 years

  • cardiovascular mortality

    10 years

Secondary Outcomes (6)

  • all-cause mortality

    10 years

  • new myocardial infarction

    10 years

  • new stroke

    10 years

  • heart failure rehospitalization

    10 years

  • quality of life

    10 years

  • +1 more secondary outcomes

Study Arms (1)

chronic heart failure

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

Other: Observational study

Interventions

Observational studyOTHER
Also known as: no intervention
chronic heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Rong Tao, Doctor

CONTACT

rongtao@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 15, 2016

First Posted

May 18, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2025

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

CN(1)