Flu Vaccination in Congestive Heart Failure (FLUVACS-IC)
|ClinicalTrials.gov Identifier: NCT00664339|
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : April 22, 2008
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 or disease||Intervention/treatment||Phase|
|Heart Failure||Biological: Flu Vaccine Other: Conventional medical therapy for heart failure||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Influenza Vaccine Pilot Study in Severe Congestive Heart Failure Patients. The Flu Vaccination Heart Failure (FLUVACS II) Study|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Active Comparator: Vaccine
Biological: Flu Vaccine
Single dose of Flu vaccine by year (1)
Conventional treatment therapy for heart failure
Other: Conventional medical therapy for heart failure
According with the international guidelines
- Total Death [ Time Frame: 6 mounths ]
- Rehospitalization for any cause or infarction [ Time Frame: 6 mounths ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664339
|Study Chair:||ENRIQUE P GURFINKEL, MD PhD||FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA|