Frailty and Mortality in Older Old With Severe Aortic Stenosis

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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

, ,

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