Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812797
• Other study ID #: 2016-38-2
• Status: Completed
• Start date: June 2016
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		Change from Baseline at 3, 6 and 12 months
Secondary	New York Heart Association (NYHA) Classification		Week:4
Secondary	re-hospitalization	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.	Change from Baseline at 3, 6 and 12 months
Secondary	plasma brain natriuretic peptide (BNP) concentration		Week:4
Secondary	Cardiovascular death		Change from Baseline at 3, 6 and 12 months
Secondary	Cardiac transplantation		Change from Baseline at 3, 6 and 12 months