EndocarditisPhase 4EASENCT00750373
Early Surgery Versus Conventional Treatment in Infective Endocarditis
A Phase 4 study testing Valve surgery with removal of vegetations in people with Endocarditis, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Endocarditis
- What is being tested?
- Valve surgery with removal of vegetations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2006to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:
- severe mitral or aortic regurgitation
- vegetation length > 10 mm on mitral or aortic valve
Who cannot join
- Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis
- Prosthetic valve endocarditis
- Patient without vegetations on echocardiography
- Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission
- Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis
- Patients who were not candidates for surgery based on age > 80 years and coexisting malignancies
- Patients who did not consent to participate
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risk of infective endocarditis.
Read the detailed description
Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of surgery was particularly high in patients with abscess formation, periannular complications, and moderate to severe heart failure related to acute mitral or aortic regurgitation. Retrospective studies reported that valve surgery was associated with improved survival, but the benefit of early surgery has not been adequately studied due to inherent treatment biases and significant differences in baseline characteristics. Embolic indications for surgery are more controversial, and surgery is usually performed in cases of recurrent emboli and persist vegetations despite appropriate antibiotic treatment. The combined risk of early surgery and valve prosthesis needs to be balanced against the potential benefit of preventing embolism and improving survival. Risk-benefit balance changes recently to favor early surgery in patients with high embolic risk of endocarditis for the following reasons. Identification of patients with high risk of embolism becomes possible with the use of transesophageal echocardiography. Patients with vegetation length > 10 mm on transesophageal echocardiography have a significantly higher risk of embolization. With advances in surgical technique, urgent surgery is feasible with low operative mortality, and the success rate of valve repair has been increased.
To the best of our knowledge, there have been no prospective outcome studies comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this multi-center, prospective, randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risks of infective endocarditis.
- Conditions
- Endocarditis
- Being tested
- Valve surgery with removal of vegetations
- Keywords
- Endocarditis
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valve surgery with removal of vegetationsProcedure or surgery
Also called early surgery
Early valve repair or replacement with removal of vegetations within 48 hours of randomization
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | Conventional Treatment based on current guidelines |
| Surgery | Active comparator | Early surgery within 48 hours of randomization Receives: Procedure: Valve surgery with removal of vegetations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With In-hospital Death or Clinical Embolic Events
The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.
Measured: within 6 weeks from the randomization
Secondary outcomes (4)
All-cause Death
Measured: up to 6 month after enrollment
Recurrences of Infective Endocarditis
Measured: up to 6 months after enrollment
All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies
Measured: up to 6 months after enrollment
Readmission Due to Development of Congestive Heart Failure
Measured: up to 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startSep 2006
- Primary completionApr 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duk-Hyun Kang, Asan Medical Center
- Investigators
- Duk-Hyun Kang, MD, PhD, Principal investigator, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750373
- Sponsor's protocol ID
- 2006-0257
- Acronym
- EASE
- Status last verified
- Apr 2015
- First submitted
- 8 Sep 2008
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kang DH, Lee S, Kim YJ, Kim SH, Kim DH, Yun SC, Song JM, Chung CH, Song JK, Lee JW. Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial. Korean Circ J. 2016 Nov;46(6):846-850. doi: 10.4070/kcj.2016.46.6.846. Epub 2016 Oct 20.
PubMed 27826345Kang DH, Kim YJ, Kim SH, Sun BJ, Kim DH, Yun SC, Song JM, Choo SJ, Chung CH, Song JK, Lee JW, Sohn DW. Early surgery versus conventional treatment for infective endocarditis. N Engl J Med. 2012 Jun 28;366(26):2466-73. doi: 10.1056/NEJMoa1112843.
PubMed 22738096
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis
- ClinicalTrials.gov ID
- NCT00750373
- Acronym / sponsor ID
- EASE / 2006-0257
- Conditions
- Endocarditis
- Keywords
- Endocarditis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 7 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risk of infective endocarditis.
Detailed description
Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of surgery was particularly high in patients with abscess formation, periannular complications, and moderate to severe heart failure related to acute mitral or aortic regurgitation. Retrospective studies reported that valve surgery was associated with improved survival, but the benefit of early surgery has not been adequately studied due to inherent treatment biases and significant differences in baseline characteristics. Embolic indications for surgery are more controversial, and surgery is usually performed in cases of recurrent emboli and persist vegetations despite appropriate antibiotic treatment. The combined risk of early surgery and valve prosthesis needs to be balanced against the potential benefit of preventing embolism and improving survival. Risk-benefit balance changes recently to favor early surgery in patients with high embolic risk of endocarditis for the following reasons. Identification of patients with high risk of embolism becomes possible with the use of transesophageal echocardiography. Patients with vegetation length > 10 mm on transesophageal echocardiography have a significantly higher risk of embolization. With advances in surgical technique, urgent surgery is feasible with low operative mortality, and the success rate of valve repair has been increased.
To the best of our knowledge, there have been no prospective outcome studies comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this multi-center, prospective, randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risks of infective endocarditis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –Conventional Treatment based on current guidelines |
| Surgery | Active comparator | Procedure: Valve surgery with removal of vegetationsEarly surgery within 48 hours of randomization |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:
Key exclusion criteria (7 listed)
- Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis
- Prosthetic valve endocarditis
- Patient without vegetations on echocardiography
- Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission
- Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis
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 |
|---|---|---|
| Valve surgery with removal of vegetationsAlso: early surgeryEarly valve repair or replacement with removal of vegetations within 48 hours of randomization | Procedure or surgery | Surgery |
Primary outcome
Number of Participants With In-hospital Death or Clinical Embolic Events
Time frame: within 6 weeks from the randomization
The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.
4 secondary outcomes
All-cause Death
Time frame: up to 6 month after enrollment
Recurrences of Infective Endocarditis
Time frame: up to 6 months after enrollment
All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies
Time frame: up to 6 months after enrollment
Readmission Due to Development of Congestive Heart Failure
Time frame: up to 6 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27826345Kang DH, Lee S, Kim YJ, Kim SH, Kim DH, Yun SC, Song JM, Chung CH, Song JK, Lee JW. Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial. Korean Circ J. 2016 Nov;46(6):846-850. doi: 10.4070/kcj.2016.46.6.846. Epub 2016 Oct 20.
- Derived from this study: PubMed 22738096Kang DH, Kim YJ, Kim SH, Sun BJ, Kim DH, Yun SC, Song JM, Choo SJ, Chung CH, Song JK, Lee JW, Sohn DW. Early surgery versus conventional treatment for infective endocarditis. N Engl J Med. 2012 Jun 28;366(26):2466-73. doi: 10.1056/NEJMoa1112843.
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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.
Duk-Hyun Kang, MD, PhD principal investigator
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valve surgery with removal of vegetations in people with Endocarditis, run by Asan Medical Center at 2 sites 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 3 inclusion and 7 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With In-hospital Death or Clinical Embolic Events (time frame: within 6 weeks from the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750373, which also lists 2 linked publications.
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 23 Apr 2015.