Age ProblemFRASER-VDNCT03365453
Frailty in Elderly Patients Receiving Surgical or Percutaneous Procedures for Valvular Disorders
A study testing frailty evaluation in people with Age Problem and Aortic Valve Disease, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Age Problem, Aortic Valve Disease, Mitral Valve Disease
- What is being tested?
- frailty evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥70
- hospital admission for valvular disorders (severe aortic stenosis or severe mitral regurgitation) requiring surgical or percutaneous intervention
Who cannot join
- SPMSQ value ≤4
- inability to stay upright
- life expectancy <3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frailty Assessment in EldeRly Admitted to HoSpital to Receive Surgical or Percutaneous Procedure for Valvular Disorders Prospective Study
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.
Read more
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.
Read the detailed description
This is a prospective study. This a single centre study involving the Maria Cecilia Hospital (Ravenna, Italy).
The study is expected to enroll at least 450 consecutive patients with ≥70 years, which are admitted for:
GROUP A: severe aortic stenosis undergoing surgical aortic valve replacement GROUP B: severe aortic stenosis undergoing transcatheter valve implantation GROUP C: severe mitral regurgitation undergoing surgical repair GROUP D: severe mitral regurgitation undergoing MITRACLIP repair
In all patients, the following functional assessments will be performed before surgical/percutaneous intervention:
handgrip test (see definition below). Short Portable Mental Status Questionnaire (SPMSQ, see definition below). Short Physical Performance Battery (SPPB, see definition below). Multidimensional Prognostic Index (MPI, see definition below). The aim of the study is to assess the relationship between frailty score and prognosis
HANDGRIP (HGT). The handgrip test measures the force of contraction of the flexor muscles of the fingers through the use of a dynamometer. From literature it is known as such index correlates with the eventual malnutrition of the subject, with its capacity of recovery and functional recovery post-surgery, as well as to be in relation with age. In each patient, three measurements will be carried out. Will be taken into consideration for the study the highest value. The measurement will be performed as indicated by current guidelines, with the patient seated, with the dominant hand and the elbow flexed 90°. All medical personnel involved in the study performed a specific course to learn the proper management and execution of screening with handgrip tes and has personal experience in its proper execution.
SHORT PHYSICAL PERFORMANCE BATTERY (SPPB). The scale SPPB is a short battery of tests created to evaluate the functionality of the lower limbs. This battery is made up of 3 different sections designed to assess a balance with 3 tests: the maintenance of the position with the feet together for 10 seconds then the semi-tandem and finally tandem again for 10 seconds. The score of this section varies from a minimum of 0 if the patient is unable to maintain position with your feet together for at least 10 seconds to a maximum of 4 if he can accomplish all three tests. The second section of the test is intended to evaluate the progress of 4 linear meters and depending on the time of the performance section of the score ranges from 0 if unable, at one point if the performance has a longer duration of 8.7 seconds, for a up to 4 if he can accomplish the task in less than 4.80 sec. The third section investigates the ability of the battery to run for 5 consecutive times, getting up from a chair without using the arms in this regard that must be crossed in front of chest. Also in this case, the score ranges from 0 incapable or if the performance has a duration greater than 60 seconds, to a maximum of 4 if such performance is carried out in less than 11.20 seconds. The scores range from 0 (worst performance) to 12 (best performance).
A score between 5 and 9 shows seniors still independent, but with reduced physical performance, which can therefore be regarded as fragile and high risk, deserving of special attention and specific interventions, acts to reduce the risk of adverse consequences. Data in the literature confirm that the SPPB correlates with the risk of developing disability in mobility, in proportion to the decrease of the SPPB score, regardless of age, sex and presence of certain chronic diseases. The SPPB score then emerges as a powerful predictor of disability and mortality in the elderly population.
MULTIDIMENSIONAL PROGNOSTIC INDEX (MPI)
The Multidimensional Prognostic Index (MPI) is a prognostic tool based on a standard Comprehensive Geriatric Assessment (CGA) that predicts short- and long-term mortality in elderly subjects. The MPI includes 63 items distributed in 8 domains of CGA as follows:
Activities of Daily Living (ADL): 6 items Instrumental Activities of Daily Living (IADL): 8 items Short Portable Mental Status Questionnaire (SPMSQ): 10 items Mini Nutritional Assessement (MNA): 18 items Exton-Smith Scale (ESS): 5 items Cumulative Index Rating Scale - Comorbidity Index (CIRS-CI): 14 items Number of drugs used: 1 item Co-habitation status: 1 item On the basis of MPI values, it is possible to calculate the short- and long-term mortality risk of the older subjects and to define the severity grade of mortality risk: low, moderate and severe. Several studies showed that the prognostic accuracy of the aggregated MPI was significantly greater than the prognostic accuracy of its individual components considered singularly. Thus the multidimensional approach can be successfully used in elderly patients for both clinical and administrative purposes.
- Conditions
- Age Problem, Aortic Valve Disease, Mitral Valve Disease
- Being tested
- frailty evaluation
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frailty evaluationOther
frailty and comorbidity scores
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: frailty evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of all-cause mortality and all-cause hospital admission
1-year cumulative incidence of all-cause mortality and all-cause hospital admission
Measured: 1-year
Secondary outcomes (3)
all-cause mortality
1-year cumulative incidence of death for all-causes
Measured: 1-year
cardiac death
1-year cumulative incidence of cardiac death
Measured: 1-year
cardiac adverse events
1-year cumulative incidence of cardiac death, myocardial infarction, heart failure
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Dec 2017
- Primary completion31 Aug 2022
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Cecilia Hospital
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
- Investigators
- Gianluca Campo, Principal investigator, Azienda Ospedaliera Universitaria di FerraraAlberto Cremonesi, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365453
- Sponsor's protocol ID
- 1949
- Acronym
- FRASER-VD
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2017
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment in EldeRly Admitted to HoSpital to Receive Surgical or Percutaneous Procedure for Valvular Disorders Prospective Study
- ClinicalTrials.gov ID
- NCT03365453
- Acronym / sponsor ID
- FRASER-VD / 1949
- Conditions
- Age Problem, Aortic Valve Disease, Mitral Valve Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Maria Cecilia Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective study. This a single centre study involving the Maria Cecilia Hospital (Ravenna, Italy).
The study is expected to enroll at least 450 consecutive patients with ≥70 years, which are admitted for:
GROUP A: severe aortic stenosis undergoing surgical aortic valve replacement GROUP B: severe aortic stenosis undergoing transcatheter valve implantation GROUP C: severe mitral regurgitation undergoing surgical repair GROUP D: severe mitral regurgitation undergoing MITRACLIP repair
In all patients, the following functional assessments will be performed before surgical/percutaneous intervention:
handgrip test (see definition below). Short Portable Mental Status Questionnaire (SPMSQ, see definition below). Short Physical Performance Battery (SPPB, see definition below). Multidimensional Prognostic Index (MPI, see definition below). The aim of the study is to assess the relationship between frailty score and prognosis
HANDGRIP (HGT). The handgrip test measures the force of contraction of the flexor muscles of the fingers through the use of a dynamometer. From literature it is known as such index correlates with the eventual malnutrition of the subject, with its capacity of recovery and functional recovery post-surgery, as well as to be in relation with age. In each patient, three measurements will be carried out. Will be taken into consideration for the study the highest value. The measurement will be performed as indicated by current guidelines, with the patient seated, with the dominant hand and the elbow flexed 90°. All medical personnel involved in the study performed a specific course to learn the proper management and execution of screening with handgrip tes and has personal experience in its proper execution.
SHORT PHYSICAL PERFORMANCE BATTERY (SPPB). The scale SPPB is a short battery of tests created to evaluate the functionality of the lower limbs. This battery is made up of 3 different sections designed to assess a balance with 3 tests: the maintenance of the position with the feet together for 10 seconds then the semi-tandem and finally tandem again for 10 seconds. The score of this section varies from a minimum of 0 if the patient is unable to maintain position with your feet together for at least 10 seconds to a maximum of 4 if he can accomplish all three tests. The second section of the test is intended to evaluate the progress of 4 linear meters and depending on the time of the performance section of the score ranges from 0 if unable, at one point if the performance has a longer duration of 8.7 seconds, for a up to 4 if he can accomplish the task in less than 4.80 sec. The third section investigates the ability of the battery to run for 5 consecutive times, getting up from a chair without using the arms in this regard that must be crossed in front of chest. Also in this case, the score ranges from 0 incapable or if the performance has a duration greater than 60 seconds, to a maximum of 4 if such performance is carried out in less than 11.20 seconds. The scores range from 0 (worst performance) to 12 (best performance).
A score between 5 and 9 shows seniors still independent, but with reduced physical performance, which can therefore be regarded as fragile and high risk, deserving of special attention and specific interventions, acts to reduce the risk of adverse consequences. Data in the literature confirm that the SPPB correlates with the risk of developing disability in mobility, in proportion to the decrease of the SPPB score, regardless of age, sex and presence of certain chronic diseases. The SPPB score then emerges as a powerful predictor of disability and mortality in the elderly population.
MULTIDIMENSIONAL PROGNOSTIC INDEX (MPI)
The Multidimensional Prognostic Index (MPI) is a prognostic tool based on a standard Comprehensive Geriatric Assessment (CGA) that predicts short- and long-term mortality in elderly subjects. The MPI includes 63 items distributed in 8 domains of CGA as follows:
Activities of Daily Living (ADL): 6 items Instrumental Activities of Daily Living (IADL): 8 items Short Portable Mental Status Questionnaire (SPMSQ): 10 items Mini Nutritional Assessement (MNA): 18 items Exton-Smith Scale (ESS): 5 items Cumulative Index Rating Scale - Comorbidity Index (CIRS-CI): 14 items Number of drugs used: 1 item Co-habitation status: 1 item On the basis of MPI values, it is possible to calculate the short- and long-term mortality risk of the older subjects and to define the severity grade of mortality risk: low, moderate and severe. Several studies showed that the prognostic accuracy of the aggregated MPI was significantly greater than the prognostic accuracy of its individual components considered singularly. Thus the multidimensional approach can be successfully used in elderly patients for both clinical and administrative purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| frailty evaluation | Experimental | Other: frailty evaluationall consecutive patients admitted to hospital for valvular disorders more than 69 years will be evaluated with several frailty and comorbidities scores. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age ≥70
- hospital admission for valvular disorders (severe aortic stenosis or severe mitral regurgitation) requiring surgical or percutaneous intervention
Key exclusion criteria (3 listed)
- SPMSQ value ≤4
- inability to stay upright
- life expectancy <3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frailty evaluationfrailty and comorbidity scores | Other | frailty evaluation |
Primary outcome
composite endpoint of all-cause mortality and all-cause hospital admission
Time frame: 1-year
1-year cumulative incidence of all-cause mortality and all-cause hospital admission
3 secondary outcomes
all-cause mortality
Time frame: 1-year
cardiac death
Time frame: 1-year
cardiac adverse events
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Campo principal investigator
Azienda Ospedaliera Universitaria di Ferrara
Alberto Cremonesi principal investigator
Maria Cecilia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing frailty evaluation in people with Age Problem and Aortic Valve Disease, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint of all-cause mortality and all-cause hospital admission (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.