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

28 november 2019 uppdaterad av: Yonsei University
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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Förväntat)

1000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Boyoung Joung, MD, PhD
  • Telefonnummer: 82-2-2228-8460
  • E-post: cby6908@yuhs.ac

Studieorter

  • Korea, Republiken av
      • Seoul, Korea, Republiken av, 120-752
        • Rekrytering
        • Severance Hospital
        • Kontakt:
          • Boyoung Joung, MD, PhD
          • Telefonnummer: 82-2-2228-8460
          • E-post: cby6908@yuhs.ac

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
ICD/CRT registry
ICD / CRTregistry in Severance or Ewha Womans University Medical Center
Procedur: ICD/CRT
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Transthoracic echocardiography (TTE)
Tidsram: before enrollment
before enrollment
Transthoracic echocardiography (TTE)
Tidsram: 12 month later afer enrollment
12 month later afer enrollment
EKG
Tidsram: before enrollment
for Ventricular arrhythmia events
before enrollment
EKG
Tidsram: 1 month later after enrollment
for Ventricular arrhythmia events
1 month later after enrollment
EKG
Tidsram: 6 month later after enrollment
for Ventricular arrhythmia events
6 month later after enrollment
EKG
Tidsram: 12 month later after enrollment
for Ventricular arrhythmia events
12 month later after enrollment
NYHA(New York Heart Association) evaluation
Tidsram: 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.
before enrollment
NYHA(New York Heart Association) evaluation
Tidsram: 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.
1 month later after enrollment
NYHA(New York Heart Association) evaluation
Tidsram: 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.
6 month later after enrollment
NYHA(New York Heart Association) evaluation
Tidsram: 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.
12 month later after enrollment
6 minute walking test
Tidsram: before enrollment
for functional capacity
before enrollment
6 minute walking test
Tidsram: 12 month later afer enrollment
for functional capacity
12 month later afer enrollment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Tidsram: before 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).
before enrollment
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
Tidsram: 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).
12 month later afer enrollment
Cardiac MRI or Cardiac CT
Tidsram: before enrollment
before enrollment
Cardiac MRI or Cardiac CT
Tidsram: 12 month later afer enrollment
12 month later afer enrollment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Yonsei University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2014

Primärt slutförande (Förväntat)

1 april 2024

Avslutad studie (Förväntat)

1 april 2024

Studieregistreringsdatum

Först inskickad

13 maj 2014

Först inskickad som uppfyllde QC-kriterierna

13 maj 2014

Första postat (Uppskatta)

15 maj 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 december 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 november 2019

Senast verifierad

1 november 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 4-2014-0098

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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Betingelser

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Platser

3
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