Cohort Study of Chronic Heart Failure

Completed

• Conditions: Analyze Etiology, Comorbidities, Clinical Characteristics
• Interventions: Other: No Intervention

• Registration Number: NCT06092658
• Lead Sponsor: Xiang Xie

Brief Summary

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.

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 Timeline

• Study Start: 2012-11-20
• Primary Completion: 2021-06-30
• Study Completion: 2022-07-14
• Study First Submitted: 2023-08-21
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Intervention	No Intervention	No Intervention

Primary Outcome Measures

Name	Time	Method
cardiac marker	Follow up will be conducted at baseline, 6 months, 12 months, and 36 months	CK，CK-MB，cTnT，cTnI，Mb
serum biochemical indicators	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
echocardiogram	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%

Secondary Outcome Measures

Name	Time	Method
Thyroid Function	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.
Coagulation function indicators	Follow up will be conducted at baseline, 6 months, 12 months, and 36 months	D-Dimer
Blood routine	Follow up will be conducted at baseline, 6 months, 12 months, and 36 months	PLT