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Flu Vaccination in Congestive Heart Failure

NCT00664339 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2008-04-22

No results posted yet for this study

Summary

We evaluated the preventive impact of vaccination on subsequent death events in 117 severe congestive heart patients requiring ventilator support without endotracheal intubations and aggressive medical therapy.

They were randomly allocated in a single-blind manner as a unique intramuscular influenza vaccination or as controls.

The first primary outcome evaluated at 6 months follow-up - cardiovascular death - occurred in 3% of the patients in the vaccine group Vs 17% in controls (p=0.022). The composite end point occurred in 33% of the patients in the vaccine group Vs 74% in control group, p = \<0.001.

Conditions

Interventions

BIOLOGICAL

Flu Vaccine

Single dose of Flu vaccine by year (1)

OTHER

Conventional medical therapy for heart failure

According with the international guidelines

Sponsors & Collaborators

  • La Fundacion Favaloro para la Investigacion y la Docencia Medica

    lead OTHER

Principal Investigators

  • ENRIQUE P GURFINKEL, MD PhD · FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-03-31
Completion
2008-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664339 on ClinicalTrials.gov