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

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.

Study Overview

• Status: Recruiting
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Procedure: ICD/CRT

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Boyoung Joung, MD, PhD; Phone Number: 82-2-2228-8460; Email: cby6908@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Hospital
    • Contact: Boyoung Joung, MD, PhD; Phone Number: 82-2-2228-8460; Email: cby6908@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transthoracic echocardiography (TTE)		before enrollment
Transthoracic echocardiography (TTE)		12 month later afer enrollment
EKG	for Ventricular arrhythmia events	before enrollment
EKG	for Ventricular arrhythmia events	1 month later after enrollment
EKG	for Ventricular arrhythmia events	6 month later after enrollment
EKG	for Ventricular arrhythmia events	12 month later after enrollment
NYHA(New York Heart Association) evaluation	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.	before enrollment
NYHA(New York Heart Association) evaluation	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.	1 month later after enrollment
NYHA(New York Heart Association) evaluation	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.	6 month later after enrollment
NYHA(New York Heart Association) evaluation	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.	12 month later after enrollment
6 minute walking test	for functional capacity	before enrollment
6 minute walking test	for functional capacity	12 month later afer enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)	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).	before enrollment
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)	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).	12 month later afer enrollment
Cardiac MRI or Cardiac CT		before enrollment
Cardiac MRI or Cardiac CT		12 month later afer enrollment

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: CRT, heart failure, ICD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 4-2014-0098