Brief Title
Frailty and Mortality in Older Old With Severe Aortic Stenosis
Official Title
Effectiveness of Physical Frailty Measurement to Determine the Outcome of Elderly Patients With Severe Symptomatic Aortic Stenosis
Brief Summary
BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with poor prognosis, the most frequent cause of heart surgery in the elderly and associates high health costs. No variables have been identified as determinants of morbidity and mortality of these patients and there are not algorithms developed for treatment decision-making in this particular population. The FS as a functional reserve indicator could be a prognostic and interventional treatment tolerance marker, and should be included in the selection of patients for surgical treatment. The FS and cardiovascular disease (CVD) share biological substrates among which an inflammatory state associates poor prognosis. OBJECTIVES .- To evaluate the effectiveness of the diagnosis of FS to characterize the prognosis of elderly patients with severe symptomatic AS representative of clinical practice. In addition, to examine the contribution of an inflammatory state to the relationship of FS with the prognosis of severe, symptomatic AS. METHODS .- Prospective study during 12 months of 200 patients > 74 years old with severe symptomatic AS. During the index visit the main clinical characteristics will be recorded and in addition we will perform a comprehensive geriatric assessment, FS assessmet according to Fried et al criteria (strength, walking speed, physical activity, fatigue, unintentional weight loss) and determination of inflammatory markers (C-reactive protein and interleukin-6). During follow-up, measures of functional impairment (basic and instrumental activities of daily living, walking speed and timed set up & go test), hospitalizations, death and quality of life will be determined.
Study Type
Observational
Primary Outcome
Mortality
Condition
Aortic Stenosis
Intervention
Frailty measurement
Study Arms / Comparison Groups
>74 years
Description: Older than 74 year-old patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
605
Start Date
February 2010
Completion Date
January 2015
Primary Completion Date
January 2015
Eligibility Criteria
Inclusion Criteria: - Severe aortic stenosis - 75 years or older - Ambulatory Exclusion Criteria: - Life expectancy lower than one year - Severe cognitive decline - Previous intervention on aortic valve
Gender
All
Ages
75 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT02745314
Organization ID
HMeixoeiro
Responsible Party
Principal Investigator
Study Sponsor
Hospital de Meixoeiro
Study Sponsor
, ,
Verification Date
April 2016