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Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)

General Information

Age Group

Adult

Status

Active

Protocol Number

N/A

Background Information

Influenza infection is known to be associated with increased risk of cardiovascular (CV) events. INVESTED is a large multicenter trial to assess the cardiopulmonary benefit of high-dose compared with standard-dose influenza vaccine in a high-risk cardiovascular population. The major potential benefits of this intervention are a) the ease of administration, b) low cost, c) 100% vaccination adherence and d) well established and extremely low risk. This trial, if positive, has the potential to substantially impact a major population attributable CV risk, change practice, and inform health policy by boosting utilization of influenza vaccination.

Offered At

Inova Cardiology Mount Vernon
8101 Hinson Farm Road #408
Alexandria, VA 22306
703-780-9014 x-1108

Inova Cardiology Manassas
8100 Ashton Avenue #200
Manassas, VA 20109
703-335-8750 x-1131

Principal Investigator

Arnold Rosenblatt, MD; Hamid Taheri, MD

Eligibility Information

Inclusion Criteria 1. Willing to give written informed consent and able to adhere to dosing and visit schedules
2. At least 18 years of age
3. Documented history of at least one of the below CV events:
a. Hospitalization for spontaneous MI (type 1 or type 2 event) (within one year of baseline visit)
b. Hospitalization for heart failure (within two years of baseline visit) but not currently acutely decompensated.
4. Fulfills at least one of the following additional risk factors:
a. Prior MI (for subjects qualifying on HF hospitalization or a second MI for those qualifying based on MI)
b. Prior HF hospitalization (for subjects qualifying based on MI or a second HF hospitalization for those qualifying based on HF)
c. Age ≥ 65 years
d. Current or historical LVEF < 40%
e. Documented diagnosis (via ICD-9 code) of type I or type II diabetes mellitus (laboratory findings, e.g., elevated A1C, FPG, plasma glucose in the absence of a clinical diagnosis is not sufficient)
f. Current BMI ≥ 30
g. Documented history of renal impairment (eGFR ≤ 60 for at least 2 readings in the past year)
h. Documented history of ischemic stroke
i. Documented history of peripheral artery disease
j. Current tobacco smoker (smokes 1 or more cigarettes daily)

Ineligibility Information

1. Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barré Syndrome within 6 weeks after influenza vaccine, or severe allergy to egg protein
2. Any non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than 9 months
3. Receipt of influenza vaccine during current influenza season
4. Any acute infection requiring antibiotics within 14 days of influenza vaccination (prophylactic antibiotics prior to dental or other procedures, or scheduled use of antibiotics for other types of prophylaxis does not exclude the subject). If an acute course of antibiotics is required, the patient may still participate in INVESTED 14 days after completing antibiotics.
5. Known fever over 100 degrees Fahrenheit or 38 degrees Celsius within 7 days of influenza vaccination
6. Women who are pregnant or breast-feeding
7. Not suitable for study participation due to other reasons at the discretion of the investigator