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Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)

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ClinicalTrials.gov Identifier: NCT02139449
Recruitment Status : Recruiting
First Posted : May 15, 2014
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
CRT and ICD has known as decreasing cardiac mortality in patient with heart failure. Especially, it has reported that CRT improved cardiac systolic function, quality of life of patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So the investigators will register patients who implant CRT or ICD (primary), and follow them up. During scheduled follow up, all patients will perform echocardiography, 6 minute walking test, EKG, Holter monitoring and questionnaire on QOL.

Condition or disease Intervention/treatment
Congestive Heart Failure Procedure: ICD/CRT

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2014
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
ICD/CRT registry
ICD / CRTregistry in Severance or Ewha Womans University Medical Center
Procedure: ICD/CRT
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation




Primary Outcome Measures :
  1. Transthoracic echocardiography (TTE) [ Time Frame: before enrollment ]
  2. Transthoracic echocardiography (TTE) [ Time Frame: 12 month later afer enrollment ]
  3. EKG [ Time Frame: before enrollment ]
    for Ventricular arrhythmia events

  4. EKG [ Time Frame: 1 month later after enrollment ]
    for Ventricular arrhythmia events

  5. EKG [ Time Frame: 6 month later after enrollment ]
    for Ventricular arrhythmia events

  6. EKG [ Time Frame: 12 month later after enrollment ]
    for Ventricular arrhythmia events

  7. NYHA(New York Heart Association) evaluation [ Time Frame: before enrollment ]

    For functional capacity

    - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.


  8. NYHA(New York Heart Association) evaluation [ Time Frame: 1 month later after enrollment ]

    For functional capacity

    - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.


  9. NYHA(New York Heart Association) evaluation [ Time Frame: 6 month later after enrollment ]

    For functional capacity

    - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.


  10. NYHA(New York Heart Association) evaluation [ Time Frame: 12 month later after enrollment ]

    For functional capacity

    - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.


  11. 6 minute walking test [ Time Frame: before enrollment ]
    for functional capacity

  12. 6 minute walking test [ Time Frame: 12 month later afer enrollment ]
    for functional capacity


Secondary Outcome Measures :
  1. Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional) [ Time Frame: before enrollment ]
    EQ-5D-3L is the scale used in the health state description part was three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).

  2. Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional) [ Time Frame: 12 month later afer enrollment ]
    EQ-5D-3L is the scale used in the health state description part was three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).

  3. Cardiac MRI or Cardiac CT [ Time Frame: before enrollment ]
  4. Cardiac MRI or Cardiac CT [ Time Frame: 12 month later afer enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with congestive heart failure(including heart failure with preserved EF or reduced EF) who are undergone cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
Criteria

Inclusion Criteria:

  1. Age >=18
  2. LV ejection fraction <40% or Clinical HF Symptom with (LV ejection fraction >40%)
  3. medication for at least 3month

Exclusion Criteria:

1. patient who refuse to enroll the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139449


Contacts
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Contact: Boyoung Joung, MD, PhD 82-2-2228-8460 cby6908@yuhs.ac

Locations
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Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Boyoung Joung, MD, PhD    82-2-2228-8460    cby6908@yuhs.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02139449    
Other Study ID Numbers: 4-2014-0098
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Keywords provided by Yonsei University:
CRT, heart failure, ICD
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases