Clinical Trial: Rationale, Design and Methods for the Early Surgery in Infective Endocarditis Study (ENDOVAL)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
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 Therapeuti
Brief Summary:
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.
Detailed Summary:
BACKGROUND Whereas mortality has been dramatically reduced in some areas of cardiac diseases thanks to continuous progress in treatment, endocarditis remains a high-mortality disease with steady percentages of mortality in the last 30 years. Several reasons may help to account for this frustrating comparison. The changing pattern of the epidemiology of endocarditis surely has contributed to the still high mortality. Patients are older, prosthetic and nosocomial endocarditis are currently more frequent, and Staphylococcus aureus has increased as the causative agent. But clinical investigators on this field must be aware of our fault in not generating evidence-based investigations. A paucity of comprehensive information exists and high-quality evidence is lacking. In fact, not even a single randomized study is available regarding the most challenging decision in endocarditis which is to decide whether and when surgery has to be undertaken in the active phase of the disease. Therefore, guidelines on treatment in endocarditis endorsed by the most prestigious scientific societies are supported by moderate (level B) or low level of evidence (level C). Not even a single recommendation on medical versus surgical treatment is based on a high level of evidence (level A). Unfortunately, it is still true that "there is still as much art as science in the care of patients with endocarditis". The only way investigators can balance the tip in favour of science is promoting randomized clinical studies with power enough to answer unsettled crucial clinical questions. Some encourage taking this track; it has been suggested by others, however, that a randomized study comparing medical versus surgical treatment in endocarditis cannot be undertaken.
American and European guidelines state with level of evidence B or C, and with subtle differences, that surgery should be considered in
Sponsor: Instituto de Ciencias del Corazon
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Instituto de Ciencias del Corazon
Dates:
Date Received: February 2, 2008
Date Started: September 2007
Date Completion: September 2010
Last Updated: February 18, 2008
Last Verified: February 2008
