Flu Vaccination in Congestive Heart Failure

NCT00664339 | Completed Phase 4 DMC

• 1 other identifier: DDI (976) 407
• Study Type: interventional
• Target: 117
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Heart failure,; infection,; immune system,; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Total Death

  6 mounths

Secondary Outcomes (1)

• Rehospitalization for any cause or infarction

  6 mounths

Study Arms (2)

Vaccine

ACTIVE COMPARATOR

Flu Vaccine

Biological: Flu Vaccine

Control

OTHER

Conventional treatment therapy for heart failure

Other: Conventional medical therapy for heart failure

Interventions

Flu Vaccine BIOLOGICAL

Single dose of Flu vaccine by year (1)

Vaccine

Conventional medical therapy for heart failure OTHER

According with the international guidelines

Control

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Those patients who were unable or refused to give a written inform consent was also excluded of the present study

Sponsors & Collaborators

• La Fundacion Favaloro para la Investigacion y la Docencia Medica: lead

MeSH Terms

Conditions

Heart Failure; Infections; Atherosclerosis

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• ENRIQUE P GURFINKEL, MD PhD

  FUNDACION FAVALORO PARA LA DOCENCIA Y LA INVESTIGACION MEDICA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 22, 2008
• Study Start: May 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 22, 2008

Record last verified: 2008-04