NCT02745314

Frailty and Mortality in Older Old With Severe Aortic Stenosis

Effectiveness of Physical Frailty Measurement to Determine the Outcome of Elderly Patients With Severe Symptomatic Aortic Stenosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 605 (actual)
• Sponsor: Hospital de Meixoeiro · Other Government
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
OTHER	Frailty measurement	Frailty measurement under Fried at el criteria
OTHER	Comprehensive Geriatric Assessment	Multidimensional Geriatric Assessment

Timeline

• Start date: 2010-02-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2016-04-20
• Last updated: 2016-04-20

Locations

1 site across 1 country: Spain