NCT02812797

Brief Summary

The purpose of this study is to determine whether expressions of adipokines can provide prognostic information concerning patients with chronic heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3.2 years

First QC Date

June 20, 2016

Last Update Submit

March 1, 2020

Conditions

Chronic Heart Failure

Keywords

AdipokinesChronic Heart FailurePrognosis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Change from Baseline at 3, 6 and 12 months

Secondary Outcomes (5)

  • New York Heart Association (NYHA) Classification

    Week:4

  • re-hospitalization

    Change from Baseline at 3, 6 and 12 months

  • plasma brain natriuretic peptide (BNP) concentration

    Week:4

  • Cardiovascular death

    Change from Baseline at 3, 6 and 12 months

  • Cardiac transplantation

    Change from Baseline at 3, 6 and 12 months

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients With Chronic Heart Failure

You may qualify if:

  • Patients who are giving open chest surgical treatment with a history of chronic heart failure (NYHA II \~ IV) more than 6 months.
  • Patients from whom informed consent has been properly obtained in writing prior to start of the trial.

You may not qualify if:

  • Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases,or any other malignancy.
  • Patients with a history of cardiomyopathy.
  • Patients with Chronic arrhythmia.
  • Pregnant women
  • Severe hepatic dysfunction or End-stage renal failure.
  • Uncontrolled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Study Officials

  • Dongying Zhang, doctor

    Chongqing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 24, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2019

Study Completion

January 1, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

CN(1)