Congestive Heart FailureNCT02139449
Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
An observational study of Congestive Heart Failure, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- ICD/CRT
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age >=18
- LV ejection fraction <40% or Clinical HF Symptom with (LV ejection fraction >40%)
- medication for at least 3month
Who cannot join
- 1. patient who refuse to enroll the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul, 120-752
Boyoung Joung, MD, PhD, 82-2-2228-8460, cby6908@yuhs.ac
About this study
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
- Being tested
- ICD/CRT
- Keywords
- CRT, heart failure, ICD
- Medical subject headings
- Heart Failure, Creatine deficiency, X-linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD/CRTProcedure or surgery
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
| Study group | Role | What they receive |
|---|---|---|
| ICD/CRT registry | ICD / CRTregistry in Severance or Ewha Womans University Medical Center Receives: Procedure: ICD/CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transthoracic echocardiography (TTE)
Measured: before enrollment
Transthoracic echocardiography (TTE)
Measured: 12 month later afer enrollment
EKG
for Ventricular arrhythmia events
Measured: before enrollment
EKG
for Ventricular arrhythmia events
Measured: 1 month later after enrollment
EKG
for Ventricular arrhythmia events
Measured: 6 month later after enrollment
EKG
for Ventricular arrhythmia events
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 month later after enrollment
6 minute walking test
for functional capacity
Measured: before enrollment
6 minute walking test
for functional capacity
Measured: 12 month later afer enrollment
Secondary outcomes (4)
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).
Measured: 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).
Measured: 12 month later afer enrollment
Cardiac MRI or Cardiac CT
Measured: before enrollment
Cardiac MRI or Cardiac CT
Measured: 12 month later afer enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139449
- Sponsor's protocol ID
- 4-2014-0098
- Status last verified
- Nov 2019
- First submitted
- 13 May 2014
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
- ClinicalTrials.gov ID
- NCT02139449
- Acronym / sponsor ID
- 4-2014-0098
- Conditions
- Congestive Heart Failure
- Keywords
- CRT, heart failure, ICD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD/CRT registry | – | Procedure: ICD/CRTICD / CRTregistry in Severance or Ewha Womans University Medical Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Age >=18
- LV ejection fraction <40% or Clinical HF Symptom with (LV ejection fraction >40%)
- medication for at least 3month
Key exclusion criteria (1 listed)
- 1. patient who refuse to enroll the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD/CRTcardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation | Procedure or surgery | ICD/CRT registry |
Primary outcome
Transthoracic echocardiography (TTE)
Time frame: before enrollment
Transthoracic echocardiography (TTE)
Time frame: 12 month later afer enrollment
EKG
Time frame: before enrollment
for Ventricular arrhythmia events
EKG
Time frame: 1 month later after enrollment
for Ventricular arrhythmia events
EKG
Time frame: 6 month later after enrollment
for Ventricular arrhythmia events
EKG
Time frame: 12 month later after enrollment
for Ventricular arrhythmia events
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.
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.
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.
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.
6 minute walking test
Time frame: before enrollment
for functional capacity
6 minute walking test
Time frame: 12 month later afer enrollment
for functional capacity
4 secondary outcomes
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Time frame: before enrollment
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Time frame: 12 month later afer enrollment
Cardiac MRI or Cardiac CT
Time frame: before enrollment
Cardiac MRI or Cardiac CT
Time frame: 12 month later afer enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boyoung Joung, MD, PhD (82-2-2228-8460, cby6908@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transthoracic echocardiography (TTE) (time frame: before enrollment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.