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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention
Other: No Intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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