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

November 28, 2012 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

admission for systolic heart failure in general hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
systolic heart failure
EF under 45%
Other: guideline adherence
guideline adherence of physician
Other Names:
  • ACEI
  • BB
  • aldosterone antagonist
  • ARB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of modified Guideline Adherence Indicator(mGAI-3)
Time Frame: 1year
Modified percentage based on each participant's condition
1year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114993

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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