Aortic StenosisSAS-frailtyNCT02745314
Frailty and Mortality in Older Old With Severe Aortic Stenosis
An observational study of Aortic Stenosis, run by Hospital de Meixoeiro at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Frailty measurement and Comprehensive Geriatric Assessment
- How many people
- 605 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Jan 2015
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older than 74 year-old patients with symptomatic severe aortic stenosis
Who may be able to join
- Severe aortic stenosis
- 75 years or older
- Ambulatory
Who cannot join
- Life expectancy lower than one year
- Severe cognitive decline
- Previous intervention on aortic valve
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Physical Frailty Measurement to Determine the Outcome of Elderly Patients With Severe Symptomatic Aortic Stenosis
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
- Being tested
- Frailty measurement, Comprehensive Geriatric Assessment
- Keywords
- Aortic Stenosis, Frailty, Elderly, moertality
- Medical subject headings
- Aortic Valve Stenosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty measurementOther
Frailty measurement under Fried at el criteria
Comprehensive Geriatric AssessmentOther
Multidimensional Geriatric Assessment
| Study group | Role | What they receive |
|---|---|---|
| >74 years | Older than 74 year-old patients Receives: Other: Frailty measurement; Other: Comprehensive Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Meixoeiro
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carlos RodrÃ-guez Pascual, Hospital de Meixoeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745314
- Sponsor's protocol ID
- HMeixoeiro
- Acronym
- SAS-frailty
- Status last verified
- Apr 2016
- First submitted
- 16 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not initially considered but open to external collaboration
Publications
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.
PubMed 31220291
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Frailty Measurement to Determine the Outcome of Elderly Patients With Severe Symptomatic Aortic Stenosis
- ClinicalTrials.gov ID
- NCT02745314
- Acronym / sponsor ID
- SAS-frailty / HMeixoeiro
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis, Frailty, Elderly, moertality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Hospital de MeixoeiroOther government
- Study start
- Feb 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| >74 years | – | Other: Frailty measurement, Other: Comprehensive Geriatric AssessmentOlder than 74 year-old patients |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older than 74 year-old patients with symptomatic severe aortic stenosis
Key inclusion criteria (3 listed)
- Severe aortic stenosis
- 75 years or older
- Ambulatory
Key exclusion criteria (3 listed)
- Life expectancy lower than one year
- Severe cognitive decline
- Previous intervention on aortic valve
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 measurementFrailty measurement under Fried at el criteria | Other | >74 years |
| Comprehensive Geriatric AssessmentMultidimensional Geriatric Assessment | Other | >74 years |
Primary outcome
Mortality
Time frame: One 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 20 Apr 2016.
- Derived from this study: PubMed 31220291Pinon 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.
- Individual participant dataSharing planned: No. Not initially considered but open to external collaboration
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Hospital de Meixoeiro at 1 site in Spain.
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 3 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 20 Apr 2016. 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 Spain. 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?
Mortality (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745314, which also lists 1 linked publication.
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 20 Apr 2016.