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Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure

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ClinicalTrials.gov Identifier: NCT02812797
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Gao Lei, Chongqing Medical University

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

Condition or disease
Chronic Heart Failure

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure
Study Start Date : June 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Change from Baseline at 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. New York Heart Association (NYHA) Classification [ Time Frame: Week:4 ]
  2. re-hospitalization [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
    Heart failure with re-hospitalization is documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needs an augmented decongestive regimen with oral or intravenous medications during an in-hospital stay.

  3. plasma brain natriuretic peptide (BNP) concentration [ Time Frame: Week:4 ]
  4. Cardiovascular death [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
  5. Cardiac transplantation [ Time Frame: Change from Baseline at 3, 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients With Chronic Heart Failure
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812797


Contacts
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Contact: Dongying Zhang, doctor +8613608398395 zdy.chris@qq.com

Locations
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China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400000
Contact: Dongying Zhang, Doctor    +8613608398395    zdy.chris@qq.com   
Principal Investigator: Lei Gao, Master         
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Study Director: Dongying Zhang, doctor Chongqing Medical University

Additional Information:

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Responsible Party: Gao Lei, Principal Investigator, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02812797     History of Changes
Other Study ID Numbers: 2016-38-2
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gao Lei, Chongqing Medical University:
Adipokines
Chronic Heart Failure
Prognosis
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases