Heart Failure Clinical Trial
An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF
Summary
The primary objective of this observational study is to determine the incidence of medically attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease [AECOPD] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.
Full Description
It is expected that this observational study will provide further understanding of the clinical impact and true incidence rates of RSV-associated hospitalizations and medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status in adults with COPD and/or CHF who are at increased risk for serious sequelae associated with RSV infections. As part of the evaluation, this study will collect symptom and physiologic data, and blood, nasal swab, and sputum in order to investigate the relationship of RSV infections with clinical endpoints.
Eligibility Criteria
Key Inclusion Criteria:
Age 50 years or greater
Hospitalization due to worsening COPD and/or CHF
Severe COPD subjects (Global Initiative for Obstructive Lung Disease Stage III/IV); FEV1 <50%
Chronic CHF subjects (New York Heart Association Class III/IV or American College of Cardiology-American Heart Association Stage C/D); Ejection fraction < 40%
Expects to have direct contact with children at least once a month
Key Exclusion Criteria:
- Participation in another clinical study involving the use of investigational product
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There are 39 Locations for this study
Birmingham Alabama, 35294, United States
Fort Smith Arkansas, 72901, United States
Denver Colorado, , United States
Bay Pines Florida, , United States
Miami Florida, , United States
Marietta Georgia, 30060, United States
Council Bluffs Iowa, 51503, United States
Minneapolis Minnesota, , United States
Reno Nevada, 89502, United States
Buffalo New York, 14215, United States
Mineola New York, 11501, United States
Rochester New York, 14621, United States
Chardon Ohio, 44024, United States
Beaver Pennsylvania, 15009, United States
Jefferson Hills Pennsylvania, 15025, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 35294, United States
Houston Texas, 77030, United States
Kingwood Texas, 77339, United States
Marshfield Wisconsin, , United States
Milwaukee Wisconsin, 53295, United States
Pleven , 5800, Bulgaria
Razgrad , 7200, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1709, Bulgaria
Sofia , , Bulgaria
Edmonton Alberta, , Canada
Vancouver British Columbia, , Canada
Hamilton Ontario, L8N 4, Canada
London Ontario, , Canada
Toronto Ontario, , Canada
Montreal Quebec, H4J 1, Canada
Montreal Quebec, , Canada
Saint-Romuald Quebec, G6W 5, Canada
Quebec , G1G 3, Canada
Jindrichuv Hradec III , 377 0, Czech Republic
Kyjov , 697 0, Czech Republic
Liberec 1 , 460 6, Czech Republic
Ostrava , 728 8, Czech Republic
Rokycany , 337 2, Czech Republic
Lyon Cedex 4 , , France
Nantes , 44093, France
Toulouse Cedex 4 , , France
Berlin , 10367, Germany
Berlin , 12203, Germany
Leipzig , 04207, Germany
Leipzig , 04275, Germany
Mannheim , 68165, Germany
Ferrara FE, 44121, Italy
Firenze FI, , Italy
Genova GE, 16132, Italy
Pisa PI, 56124, Italy
Parma PR, 43125, Italy
Moscow , , Russian Federation
Novosibirsk , , Russian Federation
Göteborg , , Sweden
Linköping , , Sweden
Lund , , Sweden
Uppsala , , Sweden
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