Rationale, Design and Methods for the Early Surgery in Infective Endocarditis Study (ENDOVAL) (ENDOVAL)
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|ClinicalTrials.gov Identifier: NCT00624091|
Recruitment Status : Unknown
Verified February 2008 by Instituto de Ciencias del Corazon.
Recruitment status was: Recruiting
First Posted : February 26, 2008
Last Update Posted : February 26, 2008
Background: Prognosis of infective endocarditis is poor and has remained steady over the last four decades. Several nonrandomized studies suggest that early surgery could improve prognosis.
Methods: The early surgery in infective endocarditis study (ENDOVAL 1) is a multicenter, prospective, randomized study designed to compare the state-of-the-art therapeutic strategy (that advised by the international societies in their guidelines) with the early surgery strategy in high-risk patients with infective endocarditis. Patients with infective endocarditis without indication for surgery will be included if they meet at least one of the following: 1) early-onset prosthetic endocarditis; 2) Staphylococcus aureus endocarditis; 3) periannular complications; 4) new-onset conduction abnormalities; 5) vegetations longer than 10 mm in diameter; 6) new-onset severe valvular disfunction. A total of 216 patients will be randomized to either of the two strategies. Stratification will be done within 3 days of admission. In the early surgery arm, the procedure will be performed within 48 hours of randomization. The only event to be considered will be death within 30 days. The study will be extended to 1 year. In the follow-up substudy, death and a new episode of endocarditis will be regarded as events.
Conclusion: The early surgery in infective endocarditis study (ENDOVAL 1), the first randomized in endocarditis, will provide crucial information regarding the putative benefit of early surgery over the state-of-the-art therapeutic approach in high-risk patients with infective endocarditis.
|Condition or disease||Intervention/treatment||Phase|
|Infective Endocarditis||Procedure: Cardiac surgery Procedure: State-to-the-art treatment||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rationale, Design and Methods for the Early Surgery in Infective Endocarditis Study: a Multicenter, Prospective, Randomized Trial Comparing the State-of-the-Art Therapeutic Strategy Versus Early Surgery Strategy in Infective Endocarditis|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||November 2007|
|Estimated Study Completion Date :||September 2010|
Early-surgery, within 48 hours from randomization
Procedure: Cardiac surgery
Cardiac surgery within 48 hours of randomization
Active Comparator: 2
State-to-the-art group. Antibiotic treatment and surgery if emergency or sequelae of endocarditis as recommended in the guidelines
Procedure: State-to-the-art treatment
Antibiotic treatment and surgery if emergency or sequelae of endocarditis as recommended in the guidelines
- In-hospital mortality rate in high-risk patients with active infective endocarditis between an early surgical approach and the state-of-the-art treatment in this disease. [ Time Frame: In-hospital mortality ]
- One year mortality rate in high-risk patients with active infective endocarditis between an early surgical approach and the state-of-the-art treatment in this disease. [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624091
|Contact: Javier López, MD, PhD||0034 616 email@example.com|
|Contact: José A San Román, PhD, FESC||0034 983 42 00 firstname.lastname@example.org|
|Universitary Hospital of Valladolid||Recruiting|
|Valladolid, Spain, 47003|
|Contact: Pedro Mota, MD 0034 983 420014 email@example.com|
|Sub-Investigator: Javier López, MD, PhD|
|Principal Investigator:||José A San Román, MD, FESC||Instituto de Ciencias del Corazon|