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

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02139449
• Other study ID #: 4-2014-0098
• Status: Recruiting
• Start date: April 2014
• Est. completion date: April 2024

Study information

• Verified date: November 2019
• Source: Yonsei University
• Contact: Boyoung Joung, MD, PhD
• Phone: 82-2-2228-8460
• Email: cby6908[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• ICD/CRT
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transthoracic echocardiography (TTE)		before enrollment
Primary	Transthoracic echocardiography (TTE)		12 month later afer enrollment
Primary	EKG	for Ventricular arrhythmia events	before enrollment
Primary	EKG	for Ventricular arrhythmia events	1 month later after enrollment
Primary	EKG	for Ventricular arrhythmia events	6 month later after enrollment
Primary	EKG	for Ventricular arrhythmia events	12 month later after enrollment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	6 minute walking test	for functional capacity	before enrollment
Primary	6 minute walking test	for functional capacity	12 month later afer enrollment
Secondary	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
Secondary	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
Secondary	Cardiac MRI or Cardiac CT		before enrollment
Secondary	Cardiac MRI or Cardiac CT		12 month later afer enrollment