To test whether valve surgery plus medical therapy is superior to medical therapy alone for treatment of endocarditis.
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Bacterial infectious disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite of one of the following criteria:
1. Death
2. New clinical stroke with persisting symptoms >24 hours from onset
3. New systemic embolization with clinical symptoms (e.g. clinical recognizable
embolization by symptoms to brain, kidney, spleen, eyes, or extremities)
4. New endocarditis event (both relapse (relapse of bacteria with the same
organism >7 days after study intervention, vegetation enlargement (>50%) or
local spreading of the vegetation) and reinfection (new endocarditis episode
after completed treatment for the initial endocarditis episode))
5. Unplanned hospitalization for new heart failure
Secondary outcome
1. Individual components of the primary endpoint at study conclusion
2. Unplanned heart valve surgery due to infective endocarditis
3. End stage renal replacement therapy in a patient without this at
randomization
4. Pacemaker or pacemaker extraction
5. Cause-specific mortality (cardiovascular and non-cardiovascular (infectious,
malignancy, other, and unknown)
6. Days in hospital,
7. Clinical status at discharge (need for help with daily activities, use of
utilities for walking, home help, discharged to nursing facility, or disability
pension)
Background summary
Infective endocarditis is a deadly disease (1/3 die within one year) and the
incidence is increasing. An important initial assessment of patients with
endocarditis includes whether surgical treatment is indicated; yet, appropriate
data to guide this assessment do not exist. The current guidelines are based on
low-level evidence and randomized data are desperately needed. The ASTERIx
study will be a novel randomized clinical trial testing a surgical approach in
addition to medical therapy against a medical therapy alone approach for
treatment of endocarditis.
Study objective
To test whether valve surgery plus medical therapy is superior to medical
therapy alone for treatment of endocarditis.
Study design
Multicenter, international, randomized, prospective study.
Patients will be allocated by randomization to valve surgery plus medical
therapy or medical therapy alone for treatment of endocarditis.
Intervention
Valve surgery plus medical therapy versus medical therapy alone.
Study burden and risks
Intervention:
1. Valve surgery plus antibiotics. Heart valve surgery is a high-risk surgical
procedure. The actual risk associated with such surgery is highly dependent on
the patient's medical history and the current severity of the disease. Current
treatment guidelines encourage surgery; however, this is not really justified
by the underlying evidence.
2. Antibiotics alone. If the hypothesis of this study is correct, disease
progression may occur in some patients in the medical therapy only arm. As a
result of this deterioration, they will undergo heart valve surgery later in
the treatment. Patients will be closely monitored during hospitalization for
any progression of the disease.
Study measurements:
Only data from the patient*s medical record are collected for this study. No
additional measurements are taken. Routine clinical checks at 1 week, 4 weeks,
3 months, and 1 year after discharge are part of standard care.
Blegdamsvej 9
Copenhagen 2100
DK
Blegdamsvej 9
Copenhagen 2100
DK
Listed location countries
Age
Inclusion criteria
• Definite left-sided infective endocarditis
AND
• Valve vegetation =>10 mm AND <=30 mm with 1 or no previous embolic event
during current infective endocarditis case
Exclusion criteria
• Unwilling to sign informed consent
• At least one clear class I recommendation for surgery because of heart
failure or uncontrolled local infection (abscess, false aneurysm, fistula)
• Unavailable for follow-up (e.g. tourist)
OR
At least one of the following criteria (unsuitable for surgery):
• Intracranial hemorrhage <1 month
• Life expectancy <1 year
• Age >=85 years
• BMI below 15 or above 45
• Possible severe liver cirrhosis (Child-Pugh Class B or worse)
• Clinical frailty score of 6 or above
• EUROSCORE II >50%
• Severe pulmonary disease (FEV1 or DLCO <30% of expected)
• Left ventricular ejection fraction <20%
• Technically inoperable (e.g. extracorporeal circulation deemed impossible)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05061355 |
| CCMO | NL80848.058.22 |