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

NCT02139449 | Unknown

• 1 other identifier: 4-2014-0098
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

CRT, heart failure, ICD

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)

  before enrollment

• Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)

  12 month later afer enrollment

• Cardiac MRI or Cardiac CT

  before enrollment

• Cardiac MRI or Cardiac CT

  12 month later afer enrollment

Study Arms (1)

ICD/CRT registry

ICD / CRTregistry in Severance or Ewha Womans University Medical Center

Procedure: ICD/CRT

Interventions

ICD/CRT PROCEDURE

cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation

ICD/CRT registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• \. patient who refuse to enroll the study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Boyoung Joung, MD, PhD

CONTACT

82-2-2228-8460; cby6908@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 3, 2019

Record last verified: 2019-11

Locations

KR (1)