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

NCT00624091 | Unknown Phase 4 DMC

• 1 other identifier: ENDOVAL-1
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Infective Endocarditis

Keywords

Early-surgery, infective endocarditis, in-hospital mortality

Outcome Measures

Primary Outcomes (1)

• 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.

  In-hospital mortality

Secondary Outcomes (1)

• 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.

  One year

Study Arms (2)

1

EXPERIMENTAL

Early-surgery, within 48 hours from randomization

Procedure: Cardiac surgery

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

Interventions

Cardiac surgery PROCEDURE

Cardiac surgery within 48 hours of randomization

1

State-to-the-art treatment PROCEDURE

Antibiotic treatment and surgery if emergency or sequelae of endocarditis as recommended in the guidelines

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with urgent/emergent indication of surgery when endocarditis is diagnosed:
• Heart failure because of valvular insufficiency.
• Fungal endocarditis.
• 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.

Sponsors & Collaborators

• Instituto de Ciencias del Corazon: lead

Study Sites (1)

Universitary Hospital of Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (2)

• Fernandez-Hidalgo N, Almirante B, Tornos P, Gonzalez-Alujas MT, Planes AM, Larrosa MN, Sambola A, Igual A, Pahissa A. Prognosis of left-sided infective endocarditis in patients transferred to a tertiary-care hospital--prospective analysis of referral bias and influence of inadequate antimicrobial treatment. Clin Microbiol Infect. 2011 May;17(5):769-75. doi: 10.1111/j.1469-0691.2010.03314.x.

  PMID: 20636419 DERIVED

• San Roman JA, Lopez J, Revilla A, Vilacosta I, Tornos P, Almirante B, Mota P, Villacorta E, Sevilla T, Gomez I, Del Carmen Manzano M, Fulquet E, Rodriguez 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. doi: 10.1016/j.ahj.2008.04.006. Epub 2008 Jul 2.

  PMID: 18760122 DERIVED

MeSH Terms

Conditions

Endocarditis

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• José A San Román, MD, FESC

  Instituto de Ciencias del Corazon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier López, MD, PhD

CONTACT

0034 616 103161; javihouston@yahoo.es

José A San Román, PhD, FESC

CONTACT

0034 983 42 00 14; asanroman@secardiologia.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2008
• First Posted: February 26, 2008
• Study Start: September 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: September 1, 2010
• Last Updated: February 26, 2008

Record last verified: 2008-02

Locations

ES (1)