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NCT Number: NCT02745314

Frailty and Mortality in Older Old With Severe Aortic Stenosis

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Meixoeiro

Vigo, Pontevedra, 36200, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty measurement

Other

Frailty measurement under Fried at el criteria

Comprehensive Geriatric Assessment

Other

Multidimensional Geriatric Assessment

Primary outcomes

  1. Mortality

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Hospital de Meixoeiro

Other Gov

Registry information

Official study title

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

Acronym: SAS-frailty

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2016
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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