Cohort Study of Chronic Heart Failure

Sponsor
Xiang Xie (Other)
Overall Status
Completed
CT.gov ID
NCT06092658
Collaborator
(none)
20,000
115.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

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 Design

Study Type:
Observational
Actual Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Cohort Study of Chronic Heart Failure
Actual Study Start Date :
Nov 20, 2012
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jul 14, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention

No Intervention

Other: No Intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. 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%

  2. cardiac marker [Follow up will be conducted at baseline, 6 months, 12 months, and 36 months]

    CK,CK-MB,cTnT,cTnI,Mb

  3. 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

Secondary Outcome Measures

  1. 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.

  2. Coagulation function indicators [Follow up will be conducted at baseline, 6 months, 12 months, and 36 months]

    D-Dimer

  3. Blood routine [Follow up will be conducted at baseline, 6 months, 12 months, and 36 months]

    RBC

  4. Blood routine [Follow up will be conducted at baseline, 6 months, 12 months, and 36 months]

    WBC

  5. Blood routine [Follow up will be conducted at baseline, 6 months, 12 months, and 36 months]

    PLT

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Xiang Xie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiang Xie, professor, Xinjiang Medical University
ClinicalTrials.gov Identifier:
NCT06092658
Other Study ID Numbers:
  • 202207-019
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023