Frailty and Mortality in Older Old With Severe Aortic Stenosis

Aortic Stenosis Clinical Trial

— SAS-frailty  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745314
• Other study ID #: HMeixoeiro
• Status: Completed
• Phase: N/A
• First received: April 16, 2016
• Last updated: April 16, 2016
• Start date: February 2010
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: Hospital de Meixoeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• Frailty measurement
Frailty measurement under Fried at el criteria
• Comprehensive Geriatric Assessment
Multidimensional Geriatric Assessment

Locations

Country	Name	City	State
Spain	Hospital Meixoeiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Meixoeiro

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		One year	No