Clinical trial NCT02745314: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: Aortic Stenosis, Frailty, Elderly, moertality
Lead sponsor: Hospital de Meixoeiro
Sponsor class: OTHER_GOV
First posted: 2016-04-20
Enrollment: 605
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older than 74 year-old patients with symptomatic severe 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.


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

Primary outcomes:
measure: Mortality
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Meixoeiro
state: Pontevedra
Study officials:
References:
citation: Pinon M, Paredes E, Acuna B, Raposeiras S, Casquero E, Ferrero A, Torres I, Legarra JJ, Pradas G, Barreiro-Morandeira F, Rodriguez-Pascual C. Frailty, disability and comorbidity: different domains lead to different effects after surgical aortic valve replacement in elderly patients. Interact Cardiovasc Thorac Surg. 2019 Sep 1;29(3):371-377. doi: 10.1093/icvts/ivz093.