Clinical Trials Logo

Clinical Trial Summary

A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and 20 patients to high dose influenza vaccine. Post-vaccine antibody measurements will be assessed, as well as tolerability differences between groups.


Clinical Trial Description

This is a randomized, double blind, active-control trial of high dose influenza vaccine compared to standard dose influenza vaccine for one season in adult participants with symptomatic heart failure(HF). The primary outcome measure is humoral (antibody-mediated) immune response, and secondary outcomes include cumulative incidence of influenza-like illness symptoms and all cause hospitalizations. The aim is to gather information on feasibility of this study design and effect size differences to inform a larger outcomes-based clinical trial. The 5.8 million Individuals in the US with heart HF are at high risk for influenza infection and associated morbidity, mortality and increased health care costs despite annual influenza vaccination. Higher dose of vaccine is approved for use in older adults. Antibody-mediated immunity contributes to vaccine-induced protection from influenza illness. Investigators at University of Wisconsin(UW) Madison have demonstrated reduced antibody titers to influenza vaccination in patients with HF. Additionally, study team has shown in a pilot study that double dose influenza vaccine resulted in increased titers and was well tolerated. A multi-center, prospective, randomized, open-label blinded-endpoint trial will be conducted with 20 participants assigned to the standard dose vaccine dose and 20 participants to high dose influenza vaccine. The primary outcome measure is the rate of seroconversion (4-fold rise in antibody titers to A/H3N2, A/H1N1, and B-type vaccine antigens), assessed 4 weeks post vaccination. The study will also examine feasibility differences in symptoms of influenza and all-cause hospitalizations between vaccine dose groups, and these data will be used for planning a subsequent outcomes-based clinical trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02268500
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Completed
Phase Phase 4
Start date September 2014
Completion date May 2016

See also
  Status Clinical Trial Phase
Completed NCT03597646 - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure N/A
Terminated NCT04065997 - Apogee International
Withdrawn NCT03675113 - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure N/A
Completed NCT02916160 - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study Phase 4
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Completed NCT02247245 - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. N/A
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT01919918 - Muscle Afferent Feedback Effects in Patients With Heart Failure Phase 1
Not yet recruiting NCT01669395 - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial N/A
Completed NCT00984529 - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia N/A
Recruiting NCT00863421 - Sleep Disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT02840565 - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 Phase 1
Completed NCT02441218 - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study Phase 3
Completed NCT00149409 - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure Phase 2/Phase 3
Terminated NCT05532046 - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) Phase 1
Recruiting NCT04984928 - Readmission Risk of Patients With Heart Failure.
Completed NCT02814097 - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05560737 - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I
Not yet recruiting NCT06002321 - Right Ventricular Dysfunction in Chronic Heart Failure