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

Heart Failure, Congestive Clinical Trial

— SUGAR  

Official title:

SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real WorldMulticenter, Retrospective Observation Study in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390935
• Other study ID #: 114993
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: November 28, 2012
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Heart Failure, Systolic

Intervention

Other:
• guideline adherence
guideline adherence of physician

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of modified Guideline Adherence Indicator(mGAI-3)	Modified percentage based on each participant's condition	1year	No
Secondary	Percentage of participants with each class drug prescribed	ARB, BB, ACE-I, aldosterone antagonist	1year	No
Secondary	Percentage of participants with daily target dose reached	ARB, BB, ACE-I, aldosterone antagonist	1year	No
Secondary	Percentage of all cause mortality	All cause mortality in 1-year after treatment of systolic heart failure	1year	No
Secondary	Percentage of All cause hospitalization	All cause hospitalization in 1-year after treatment of systolic heart failure	1year	No
Secondary	Mean of mortality or rehospitalization rate according to mGAI-3		1year	No