Frailty and Mortality in Older Old With Severe Aortic Stenosis

NCT02745314 | Completed

• 1 other identifier: HMeixoeiro
• Study Type: observational
• Target: 605
• Locations: 1 country
• Sites: 1

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

Keywords

Aortic Stenosis, Frailty, Elderly, moertality

Outcome Measures

Primary Outcomes (1)

• Mortality

  One year

Study Arms (1)

>74 years

Older than 74 year-old patients

Other: Frailty measurement; Other: Comprehensive Geriatric Assessment

Interventions

Frailty measurement OTHER

Frailty measurement under Fried at el criteria

>74 years

Comprehensive Geriatric Assessment OTHER

Multidimensional Geriatric Assessment

>74 years

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older than 74 year-old patients with symptomatic severe aortic stenosis

You may qualify if:

• Severe aortic stenosis
• years or older
• Ambulatory

You may not qualify if:

• Life expectancy lower than one year
• Severe cognitive decline
• Previous intervention on aortic valve

Sponsors & Collaborators

• Hospital de Meixoeiro: lead

Study Sites (1)

Hospital Meixoeiro

Vigo, Pontevedra, 36200, Spain

Location

Related Publications (1)

• 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.

  PMID: 31220291 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum plasma samples

MeSH Terms

Conditions

Aortic Valve Stenosis; Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 16, 2016
• First Posted: April 20, 2016
• Study Start: February 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)