SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World

Completed

• Conditions: Heart Failure, Congestive

• Registration Number: NCT01390935
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to survey the guideline compliance of the cardiologists in the treatment of systolic heart failure in Korea

Detailed Description

Major improvement in the medical management of CHF has been achieved in the past decades.

But there is no doubt that prognosis of heart failure patients remains poor. The compliance to the standard treatment can be one of reasons. But very little data concerning this in Korea is available.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-28
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009
• Subjects, age 20 or/and above
• Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria;
• Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly
• Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration

Exclusion Criteria

• Subject who expired during hospitalization

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean of modified Guideline Adherence Indicator(mGAI-3)	1year	Modified percentage based on each participant's condition

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with each class drug prescribed	1year	ARB, BB, ACE-I, aldosterone antagonist
Percentage of participants with daily target dose reached	1year	ARB, BB, ACE-I, aldosterone antagonist
Percentage of all cause mortality	1year	All cause mortality in 1-year after treatment of systolic heart failure
Percentage of All cause hospitalization	1year	All cause hospitalization in 1-year after treatment of systolic heart failure
Mean of mortality or rehospitalization rate according to mGAI-3	1year

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of