Flu Vaccination in Congestive Heart Failure (FLUVACS-IC)

April 17, 2008 updated by: La Fundacion Favaloro para la Investigacion y la Docencia Medica

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vaccine
Flu Vaccine
Biological: Flu Vaccine
Single dose of Flu vaccine by year (1)
Other: Control
Conventional treatment therapy for heart failure
Other: Conventional medical therapy for heart failure
According with the international guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Death
Time Frame: 6 mounths
6 mounths

Secondary Outcome Measures

Outcome Measure
Time Frame
Rehospitalization for any cause or infarction
Time Frame: 6 mounths
6 mounths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

La Fundacion Favaloro para la Investigacion y la Docencia Medica

Investigators

  • Study Chair: ENRIQUE P GURFINKEL, MD PhD, FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 17, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDI (976) 407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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