Heart Failure, CongestiveSUGARNCT01390935
SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World
An observational study of Heart Failure, Congestive, run by GlaxoSmithKline at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- guideline adherence
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to May 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: admission for systolic heart failure in general hospital
Who may be able to join
- 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
Who cannot join
- Subject who expired during hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Heart Failure, Congestive
- Being tested
- guideline adherence
- Keywords
- guideline adherence, systolic heart failure
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guideline adherenceOther
Also called ACEI, ARB, BB, aldosterone antagonist
guideline adherence of physician
| Study group | Role | What they receive |
|---|---|---|
| systolic heart failure | EF under 45% Receives: Other: guideline adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of modified Guideline Adherence Indicator(mGAI-3)
Modified percentage based on each participant's condition
Measured: 1year
Secondary outcomes (5)
Percentage of participants with each class drug prescribed
ARB, BB, ACE-I, aldosterone antagonist
Measured: 1year
Percentage of participants with daily target dose reached
ARB, BB, ACE-I, aldosterone antagonist
Measured: 1year
Percentage of all cause mortality
All cause mortality in 1-year after treatment of systolic heart failure
Measured: 1year
Percentage of All cause hospitalization
All cause hospitalization in 1-year after treatment of systolic heart failure
Measured: 1year
Mean of mortality or rehospitalization rate according to mGAI-3
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390935
- Sponsor's protocol ID
- 114993
- Acronym
- SUGAR
- Status last verified
- Nov 2012
- First submitted
- 9 Jun 2011
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real WorldMulticenter, Retrospective Observation Study in Korea
- ClinicalTrials.gov ID
- NCT01390935
- Acronym / sponsor ID
- SUGAR / 114993
- Conditions
- Heart Failure, Congestive
- Keywords
- guideline adherence, systolic heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Jul 2011 (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.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| systolic heart failure | – | Other: guideline adherenceEF under 45% |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- admission for systolic heart failure in general hospital
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subject who expired during hospitalization
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 |
|---|---|---|
| guideline adherenceAlso: ACEI, ARB, BB, aldosterone antagonistguideline adherence of physician | Other | systolic heart failure |
Primary outcome
Mean of modified Guideline Adherence Indicator(mGAI-3)
Time frame: 1year
Modified percentage based on each participant's condition
5 secondary outcomes
Percentage of participants with each class drug prescribed
Time frame: 1year
Percentage of participants with daily target dose reached
Time frame: 1year
Percentage of all cause mortality
Time frame: 1year
Percentage of All cause hospitalization
Time frame: 1year
Mean of mortality or rehospitalization rate according to mGAI-3
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Heart Failure, Congestive, run by GlaxoSmithKline 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 5 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: finished, as of the sponsor's last update on 30 Nov 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of modified Guideline Adherence Indicator(mGAI-3) (time frame: 1year). 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 30 Nov 2012.