Cohort Study of Chronic Heart Failure

October 19, 2023 updated by: Xiang Xie
The purpose is to understand the clinical characteristics of chronic heart failure as soon as possible, analyze the etiology, comorbidities, clinical characteristics, and treatment of heart failure patients, observe the gap between real-world clinical practice and guideline recommendations, and provide reference for the improvement of heart failure prevention and treatment in China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria:

  1. Accompanied by difficulty breathing, fatigue, or decreased activity tolerance;
  2. Signs of fluid retention (pulmonary congestion and peripheral edema);
  3. Echocardiography shows abnormalities in cardiac structure and/or function;
  4. Elevated levels of natriuretic peptide: B-type natriuretic peptide (BNP)>35 ng/L and/or N-terminal B-type proBNP (NT proBNP)>125 ng/L.
  5. HF hospitalization recorded within the previous 12 months

Exclusion criteria:

  1. Concomitant severe liver function, renal failure, or other severe system dysfunction
  2. Poor compliance, inability to obtain information, or voluntary refusal to participate in this study.

Study Type

Observational

Enrollment (Actual)

20000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Accompanied by difficulty breathing, fatigue, or decreased activity tolerance;
  2. Signs of fluid retention (pulmonary congestion and peripheral edema);
  3. Echocardiography shows abnormalities in cardiac structure and/or function;
  4. Elevated levels of natriuretic peptide: B-type natriuretic peptide (BNP)>35 ng/L and/or N-terminal B-type proBNP (NT proBNP)>125 ng/L.

Exclusion Criteria:

  1. Concomitant severe liver function, renal failure, or other severe system dysfunction
  2. Poor compliance, inability to obtain information, or voluntary refusal to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Intervention
Other: No Intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
echocardiogram
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
ejection fraction,Consider heart failure when the ejection fraction is less than 50%
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
cardiac marker
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
CK，CK-MB，cTnT，cTnI，Mb
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
serum biochemical indicators
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
HDL-cholesterol, mg/dL，LDL-cholesterol, mg/dL，Total cholesterol, mg/dL，Triglycerides, mg/dL
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid Function
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
thyroid hormone,Thyroid hormone blood testing: This is the most commonly used method to measure thyroid hormone levels in the blood. Common thyroid hormone indicators include thyroxine, free thyroxine, triiodothyronine, and free triiodothyronine.
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
Coagulation function indicators
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
D-Dimer
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
Blood routine
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
RBC
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
Blood routine
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
WBC
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
Blood routine
Time Frame: Follow up will be conducted at baseline, 6 months, 12 months, and 36 months
PLT
Follow up will be conducted at baseline, 6 months, 12 months, and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiang Xie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2012

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 14, 2022

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202207-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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