Heart FailurePhase 4FLUVACS-ICNCT00664339
Flu Vaccination in Congestive Heart Failure
A Phase 4 study testing Flu Vaccine and Conventional medical therapy for heart failure in people with Heart Failure, run by La Fundacion Favaloro para la Investigacion y la Docencia Medica.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Flu Vaccine and Conventional medical therapy for heart failure
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
Official title: Influenza Vaccine Pilot Study in Severe Congestive Heart Failure Patients. The Flu Vaccination Heart Failure (FLUVACS II) Study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Flu Vaccine, Conventional medical therapy for heart failure
- Keywords
- Heart failure,, infection,, immune system,, atherosclerosis
- Medical subject headings
- Heart Failure, Infections, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu VaccineBiological
Single dose of Flu vaccine by year (1)
Conventional medical therapy for heart failureOther
According with the international guidelines
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Active comparator | Flu Vaccine Receives: Biological: Flu Vaccine |
| Control | Other | Conventional treatment therapy for heart failure Receives: Other: Conventional medical therapy for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Death
Measured: 6 mounths
Secondary outcomes (1)
Rehospitalization for any cause or infarction
Measured: 6 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Fundacion Favaloro para la Investigacion y la Docencia Medica
- Sponsor type
- University, hospital or other
- Investigators
- ENRIQUE P GURFINKEL, MD PhD, Study chair, FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664339
- Sponsor's protocol ID
- DDI (976) 407
- Acronym
- FLUVACS-IC
- Status last verified
- Apr 2008
- First submitted
- 17 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccine Pilot Study in Severe Congestive Heart Failure Patients. The Flu Vaccination Heart Failure (FLUVACS II) Study
- ClinicalTrials.gov ID
- NCT00664339
- Acronym / sponsor ID
- FLUVACS-IC / DDI (976) 407
- Conditions
- Heart Failure
- Keywords
- Heart failure,, infection,, immune system,, atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- La Fundacion Favaloro para la Investigacion y la Docencia MedicaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Active comparator | Biological: Flu VaccineFlu Vaccine |
| Control | Other | Other: Conventional medical therapy for heart failureConventional treatment therapy for heart failure |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flu VaccineSingle dose of Flu vaccine by year (1) | Biological | Vaccine |
| Conventional medical therapy for heart failureAccording with the international guidelines | Other | Control |
Primary outcome
Total Death
Time frame: 6 mounths
1 secondary outcome
Rehospitalization for any cause or infarction
Time frame: 6 mounths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ENRIQUE P GURFINKEL, MD PhD study chair
FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flu Vaccine and Conventional medical therapy for heart failure in people with Heart Failure, run by La Fundacion Favaloro para la Investigacion y la Docencia Medica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Death (time frame: 6 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2008.