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Clinical Trials/NCT02745314
NCT02745314CompletedNot Applicable

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

Hospital de Meixoeiro1 site in 1 country605 target enrollmentStarted: February 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
605
Locations
1
Primary Endpoint
Mortality

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
75 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Mortality

Time Frame: One year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital de Meixoeiro
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Carlos RodrÃ-guez Pascual

MD, PhD

Hospital de Meixoeiro

Study Sites (1)

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