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Sponsored by: |
La Fundacion Favaloro para la Investigacion y la Docencia Medica |
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Information provided by: | La Fundacion Favaloro para la Investigacion y la Docencia Medica |
ClinicalTrials.gov Identifier: | NCT00664339 |
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.
Condition | Intervention | Phase |
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Heart Failure |
Biological: Flu Vaccine Other: Conventional medical therapy for heart failure |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Influenza Vaccine Pilot Study in Severe Congestive Heart Failure Patients. The Flu Vaccination Heart Failure (FLUVACS II) Study |
Enrollment: | 117 |
Study Start Date: | May 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Vaccine: Active Comparator
Flu Vaccine
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Biological: Flu Vaccine
Single dose of Flu vaccine by year (1)
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Control
Conventional treatment therapy for heart failure
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Other: Conventional medical therapy for heart failure
According with the international guidelines
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Background: Recent reports detected that one of the barriers that vaccination against influenza infection is that, physicians do not strongly recommend its applications to cardiovascular patients at risk. We evaluated the preventive impact of vaccination against death in severe congestive heart failure hospitalized patients. Methods and Results: A total of 117 severe congestive heart failure patients (New York Heart Association class III and IV) admitted in the first 12 hours who required ventilator support without endotracheal intubations and high doses of loop-diuretics, were included in a prospective, multicenter log, during the winter season. Congestive heart patients received intravenous vasodilators and loop-diuretics plus standard therapies, and then were randomly allocated in a single-blind manner as a unique intramuscular influenza vaccination or as controls. Death, and combined end points (death, and re-hospitalization for any reason) were assessed at 6 months follow-up. The first primary outcome - cardiovascular death - occurred in 3% of the patients in the vaccine group Vs 17% in controls (odds ratio with vaccine as compared with controls: 0.16; 95 percent confidence interval, 0.33 to 0.79; p=0.022). The composite end point occurred in 33% of the patients in the vaccine group Vs 74% in controls, p = <0.001. The need of adding inotropic drugs occurred in 8% of patients receiving vaccination, and in 12.5% in the control group.
Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Definite evidence of underlying heart failure was also required as shown by at least two of the following:
Exclusion Criteria:
Responsible Party: | Fundacion Favaloro para la Docencia y la Investigacion Medica ( ENRIQUE P. GURFINKEL, MD PhD ) |
Study ID Numbers: | DDI (976) 407 |
Study First Received: | April 17, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00664339 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Heart failure, infection, immune system, atherosclerosis |
Atherosclerosis Heart Failure Heart Diseases Influenza, Human |
Heart Failure Heart Diseases Cardiovascular Diseases |