A trial to study role of influenza vaccine in reducing heart attack, stroke, hospitalisation and death in patients of heart failure.
Phase 4
- Conditions
- Health Condition 1: null- Heart Failure
- Registration Number
- CTRI/2016/07/007081
- Lead Sponsor
- McMaster University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 3500
Inclusion Criteria
New York Heart Association(NYHA) functional class II, III and IV.
Exclusion Criteria
a) Anaphylactic reaction to a previous dose of TIV.
b) Known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock.
c) Guillain-Barré syndrome within eight weeks of a previous influenza vaccine.
d) Anaphylactic reaction to neomycin.
e) Patients who have had influenza vaccine in two of the three previous years.
f) Patients with severe valvular disease that are candidates for surgical or percutaneous valve repair or replacement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is a composite of cardiovascular (CV) death, non-fatal Myocardial Infarction, non- fatal stroke, and hospitalization for Heart Failure.Timepoint: 3 Years
- Secondary Outcome Measures
Name Time Method The secondary outcome will be analyse cardiovascular death alone during the period of study.Timepoint: 3 Years