Back to resultsFlu Vaccination in Congestive Heart Failure (FLUVACS-IC)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Flu Vaccine
Conventional medical therapy for heart failure
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring Heart failure,, infection,, immune system,, atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- Male or female patient's > 21 years of age with a severe congestive heart failure (New York Heart Association class III or IV) requiring an immediate administration of intravenous vasodilators drugs, oxygen therapy, and no less than 160 mg of intravenous furosemide were eligible for inclusion.
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 a concomitant infective disease were excluded from the study
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Vaccine
Control
Arm Description
Flu Vaccine
Conventional treatment therapy for heart failure
Outcomes
Primary Outcome Measures
Total Death
Secondary Outcome Measures
Rehospitalization for any cause or infarction
Full Information
NCT ID
NCT00664339
First Posted
April 17, 2008
Last Updated
April 17, 2008
Sponsor
La Fundacion Favaloro para la Investigacion y la Docencia Medica
1. Study Identification
Unique Protocol Identification Number
NCT00664339
Brief Title
Flu Vaccination in Congestive Heart Failure
Acronym
FLUVACS-IC
Official Title
Influenza Vaccine Pilot Study in Severe Congestive Heart Failure Patients. The Flu Vaccination Heart Failure (FLUVACS II) Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
La Fundacion Favaloro para la Investigacion y la Docencia Medica
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure,, infection,, immune system,, atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Active Comparator
Arm Description
Flu Vaccine
Arm Title
Control
Arm Type
Other
Arm Description
Conventional treatment therapy for heart failure
Intervention Type
Biological
Intervention Name(s)
Flu Vaccine
Intervention Description
Single dose of Flu vaccine by year (1)
Intervention Type
Other
Intervention Name(s)
Conventional medical therapy for heart failure
Intervention Description
According with the international guidelines
Primary Outcome Measure Information:
Title
Total Death
Time Frame
6 mounths
Secondary Outcome Measure Information:
Title
Rehospitalization for any cause or infarction
Time Frame
6 mounths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient's > 21 years of age with a severe congestive heart failure (New York Heart Association class III or IV) requiring an immediate administration of intravenous vasodilators drugs, oxygen therapy, and no less than 160 mg of intravenous furosemide were eligible for inclusion.
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 a concomitant infective disease were excluded from the study
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ENRIQUE P GURFINKEL, MD PhD
Organizational Affiliation
FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Flu Vaccination in Congestive Heart Failure
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