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NCT02787044 · ClinicalTrials.gov registry record · Phase 4

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure

A Phase 4 study of Heart Failure and Myocardial Infarction, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 4
Development phase
5,388
Enrollment target
20
Study locations

NCT02787044 is a Phase 4 study of Heart Failure and Myocardial Infarction that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 5,388 participants, above the 2,035-participant average among 397 other Heart Failure trials with a reported enrollment target (165% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT02787044, a Phase 4 study of Heart Failure and Myocardial Infarction, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 4
Development phase
5,388 participants
Enrollment target
20
Study locations

Study Summary

INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.

Interventions

  • BIOLOGICAL High Dose Trivalent Influenza Vaccine
  • BIOLOGICAL Standard Dose Quadrivalent Influenza Vaccine

Study Locations (20)

Florida

  • Clearwater Cardiovascular Consultants - Clearwater
  • N FL/S GA Veterans Health System - Gainesville
  • OneFlorida CDRN - Gainesville
  • Clearwater Cardiovascular Consultants-Largo - Largo
  • Inpatient Research Corporation - Miami
  • ITB Research - Miami

California

  • VA Loma Linda Healthcare System - Loma Linda
  • Long Beach VAMC - Long Beach
  • University of California Davis Medical Center - Sacramento
  • VA San Diego Healthcare System - San Diego
  • UCSF Medical Center - San Francisco

Alabama

  • Birmingham VAMC - Birmingham
  • University of Alabama Hypertension Program - Birmingham
  • Heart Center Research, LLC - Huntsville

Arizona

  • Banner University Medicine North - Tucson
  • University of Arizona- Sarver Heart Center - Tucson

Alaska

  • Alaska Heart & Vascular Institute - Anchorage

Arkansas

  • CAVHS - Little Rock

Connecticut

  • VA West Haven - West Haven

District of Columbia

  • Washington DC VAMC - Washington D.C.

Trial Details

FieldValue
Enrollment Target 5,388 participants
Start Date 2016-08-01
Est. Completion 2020-05-31
Phase Phase 4

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT02787044

The ClinicalTrials.gov registry entry for NCT02787044 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 5,388 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,035-participant average among 397 other Heart Failure trials with a reported enrollment target (165% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which High Dose Trivalent Influenza Vaccine is the first listed.

NCT02787044 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT02787044 about?

NCT02787044 is a clinical study titled "INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure". INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will e...

What is the current status of trial NCT02787044?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 5,388 participants. The study started on 2016-08-01. Estimated completion is 2020-05-31.

What conditions does trial NCT02787044 study?

This clinical trial studies the following conditions: Heart Failure, Myocardial Infarction.

What interventions are being tested in trial NCT02787044?

The interventions under investigation include: High Dose Trivalent Influenza Vaccine (BIOLOGICAL), Standard Dose Quadrivalent Influenza Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02787044?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02787044 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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