Frailty in Elderly Patients Receiving Surgical or Percutaneous Procedures for Valvular Disorders

NCT03365453 | Completed DMC

• 1 other identifier: 1949
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality of many diseases. Yet, chronic diseases are nowadays more important, and often coexist as comorbidity or multimorbidity, depending on whether an index condition has been considered. These conditions increase the risk of death and reduce functional autonomy in the elderly and, therefore, should be carefully considered within comprehensive geriatric assessment. The epidemiology of valvular disease shows a clear trend in age-dependent, as the number of events and their incidence increases with age, and about half are concentrates over 75 years. In addition, some observational studies in elderly patients have suggested an association between frailty and cardiovascular disease: fragility and cardiovascular disease share a common biological pathway, and cardiovascular diseases may accelerate the onset of frailty. The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease, according to the rating scale used and the population studied. Frail patients with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease and aortic valve disease, have a much higher adverse events and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures. Among the numerous tests proposed in the literature for the functional evaluation and objective measures of physical capability in elderly patient, the Short Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those characterized by an improved prognostic ability and an easy administration. The present study is performed to assess if SPPB and handgrip are helpful to better stratify the prognosis (all-causes death and hospital admission for all causes) in elderly patients admitted to hospital for cardiac causes.

Conditions

Age Problem; Aortic Valve Disease; Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• composite endpoint of all-cause mortality and all-cause hospital admission

  1-year cumulative incidence of all-cause mortality and all-cause hospital admission

  1-year

Secondary Outcomes (3)

• all-cause mortality

  1-year

• cardiac death

  1-year

• cardiac adverse events

  1-year

Other Outcomes (1)

• cerebrovascular accident

  1-year

Study Arms (1)

frailty evaluation

EXPERIMENTAL

all consecutive patients admitted to hospital for valvular disorders more than 69 years will be evaluated with several frailty and comorbidities scores.

Other: frailty evaluation

Interventions

frailty evaluation OTHER

frailty and comorbidity scores

frailty evaluation

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥70
• hospital admission for valvular disorders (severe aortic stenosis or severe mitral regurgitation) requiring surgical or percutaneous intervention

You may not qualify if:

• SPMSQ value ≤4
• inability to stay upright
• life expectancy \<3 months

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Maria Cecilia Hospital: collaborator

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Gianluca Campo

  Azienda Ospedaliera Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

• Alberto Cremonesi

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 7, 2017
• Study Start: December 1, 2017
• Primary Completion: August 31, 2022
• Study Completion: December 7, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

IT (1)