Frailty and Mortality in Older Old With Severe Aortic Stenosis

NCT ID: NCT02745314

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 605 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2015-01-31

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.

Conditions

Aortic Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

>74 years

Older than 74 year-old patients

Frailty measurement

Intervention Type: OTHER

Frailty measurement under Fried at el criteria

Comprehensive Geriatric Assessment

Intervention Type: OTHER

Multidimensional Geriatric Assessment

Interventions

Frailty measurement

Frailty measurement under Fried at el criteria

Intervention Type: OTHER

Comprehensive Geriatric Assessment

Multidimensional Geriatric Assessment

Intervention Type: OTHER

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Meixoeiro

OTHER_GOV

Sponsor Role: lead

Responsible Party

Carlos RodrÃ-guez Pascual

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Meixoeiro

Vigo, Pontevedra, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 31220291 (View on PubMed)

Other Identifiers

HMeixoeiro

Identifier Type: -

Identifier Source: org_study_id