Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
117 participants
INTERVENTIONAL
2007-05-31
2008-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Vaccine
Flu Vaccine
Flu Vaccine
Single dose of Flu vaccine by year (1)
Control
Conventional treatment therapy for heart failure
Conventional medical therapy for heart failure
According with the international guidelines
Interventions
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Flu Vaccine
Single dose of Flu vaccine by year (1)
Conventional medical therapy for heart failure
According with the international guidelines
Eligibility Criteria
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Inclusion Criteria
* Definite evidence of underlying heart failure was also required as shown by at least two of the following:
* a) Orthopnea on admission
* b) X-ray showing evidences of elevated wedge pressure indicating congestive heart failure
* c) recent prior hospitalization (within the 30 days prior to the index hospitalization) because a congestive heart failure episode
* d) echocardiography data showing a poor left ventricular ejection fraction (0.40 or lower measuring with the biplane Simpson's method
* e) non-invasive ventilation to the maintenance of SaO2 above 90%
* f) wet rales in at least the lower half of the lungs fields
* Patients with a final diagnosis of Congestive Heart Failure as a consequence of necrotic or chronic ischemic heart disease, or infective origin such as chronic Chagas Disease, chronic valvular heart disease (surgically repaired or not), and idiopathic origin were also included for the present study
Exclusion Criteria
* Patients with evidence of evolving with multi organic failure (hepatic or renal dysfunction requiring dialysis), terminal disease, or any impeding cause of follow-up, including contraindications of vaccination, were excluded from the study
* Those with congestive heart failure following unstable coronary artery disease, or prior by-pass surgery, or angioplasty or congestive heart failure complicating myocardial infarction requiring urgent intervention were excluded also
* Those individuals who required mechanical ventilation on admission
* Patients with prior vaccinations were also excluded
* Pregnancy condition was an exclusion criterion
* Those patients who were unable or refused to give a written inform consent was also excluded of the present study
21 Years
90 Years
ALL
No
Sponsors
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La Fundacion Favaloro para la Investigacion y la Docencia Medica
OTHER
Responsible Party
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Fundacion Favaloro para la Docencia y la Investigacion Medica
Principal Investigators
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ENRIQUE P GURFINKEL, MD PhD
Role: STUDY_CHAIR
FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA
Other Identifiers
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DDI (976) 407
Identifier Type: -
Identifier Source: org_study_id