Rationale, Design and Methods for the Early Surgery in Infective Endocarditis Study (ENDOVAL) - Full Text View

Sponsor:	Instituto de Ciencias del Corazon
Information provided by:	Instituto de Ciencias del Corazon
ClinicalTrials.gov Identifier:	NCT00624091

Purpose

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	Intervention	Phase
Infective Endocarditis	Procedure: Cardiac surgery Procedure: State-to-the-art treatment	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Endocarditis Heart Surgery Surgery

U.S. FDA Resources

Further study details as provided by Instituto de Ciencias del Corazon:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	216
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Early-surgery, within 48 hours from randomization	Procedure: Cardiac surgery Cardiac surgery within 48 hours of randomization
2: Active Comparator 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

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients older than 18 years.
Infective endocarditis diagnosed by modified Duke criteria.
At least one of the following risk factors:
1. Periannular complications
2. New onset auriculo-ventricular block
3. New onset severe valvular insufficiency
4. Early-onset prosthetic valve endocarditis
5. Staphylococcus aureus endocarditis
6. Vegetations greater than 20 mm

Exclusion Criteria:

Patients with urgent/emergent indication of surgery when endocarditis is diagnosed:
1. Heart failure because of valvular insufficiency.
2. Fungal endocarditis.
3. Septic shock.
Patients referred from other centers to be operated on.
Patients without echocardiographic evidence of endocarditis.
Pregnant or lactating women.
Simultaneous participation in other research study.
Incapacity to mantein the conditions of the study.
Patients referred from other centers more than 5 days after the diagnosis of infective endocarditis.
Patients with prohibitive risk for surgery due to comorbidities, estimated by previous validated scales. An Euroescore value greater than 40% will be considered a contraindication to enter the protocol.
Patients with ischemic or haemorragic stroke within one month before the diagnosis of endocarditis.
Endocarditis in intravenous drug addicts patients.
Not signed the inform consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624091

Contacts

Contact: Javier López, MD, PhD	0034 616 103161	javihouston@yahoo.es
Contact: José A San Román, PhD, FESC	0034 983 42 00 14	asanroman@secardiologia.es

Locations

Spain
Universitary Hospital of Valladolid	Recruiting
Valladolid, Spain, 47003
Contact: Pedro Mota, MD 0034 983 420014 motagomezp@hotmail.com
Sub-Investigator: Javier López, MD, PhD

Sponsors and Collaborators

Instituto de Ciencias del Corazon

Investigators

Principal Investigator:

José A San Román, MD, FESC

Instituto de Ciencias del Corazon

More Information

No publications provided by Instituto de Ciencias del Corazon

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

San Román JA, López J, Revilla A, Vilacosta I, Tornos P, Almirante B, Mota P, Villacorta E, Sevilla T, Gómez I, Del Carmen Manzano M, Fulquet E, Rodríguez E, Igual A. Rationale, design, and methods for the early surgery in infective endocarditis study (ENDOVAL 1): a multicenter, prospective, randomized trial comparing the state-of-the-art therapeutic strategy versus early surgery strategy in infective endocarditis. Am Heart J. 2008 Sep;156(3):431-6. Epub 2008 Jul 2.

Responsible Party:	ICICOR ( Jose Alberto San Román Calvar )
Study ID Numbers:	ENDOVAL-1
Study First Received:	February 2, 2008
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00624091 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto de Ciencias del Corazon:

Early-surgery, infective endocarditis, in-hospital mortality

Additional relevant MeSH terms:

Bacterial Infections
Heart Diseases
Endocarditis, Bacterial
Cardiovascular Diseases

Cardiovascular Infections
Infection
Endocarditis

ClinicalTrials.gov processed this record on March 18, 2010