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

• Conditions: Congestive Heart Failure

• Registration Number: NCT02139449
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-03
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EKG	12 month later after enrollment	for Ventricular arrhythmia events
NYHA(New York Heart Association) evaluation	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.
Transthoracic echocardiography (TTE)	12 month later afer enrollment
6 minute walking test	12 month later afer enrollment	for functional capacity

Secondary Outcome Measures

Name	Time	Method
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)	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).
Cardiac MRI or Cardiac CT	12 month later afer enrollment

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of