Heart FailureNCT03887351
Frailty Heart Failure Study
An observational study of Heart Failure and Frail Elderly Syndrome, run by Jewish General Hospital.
Trial summary
A prospective longitudinal cohort study aimed at measuring frailty and its associated risk factors community dwelling older adults aged 65 years or older. The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Frail Elderly Syndrome
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Nov 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population is determined using the inclusion and exclusion criteria. Study population will be Montreal based.
Who may be able to join
- Community dwelling outpatients
- Aged 65 years or older
- A HF diagnosis with preserved or reduced ejection fraction for at least 3 months
- Agreed to participate and signed an informed consent form
Who cannot join
- Outpatients with a recent hospital admission within 3 months
- Acutely decompensated HF status at the time of their visit
- Received intravenous (IV) diuretics or IV inotropes within 3 months
- A moribund health status with life expectancy less than 3 months
- Scheduled to undergo a major surgical or percutaneous procedure within 3 months
- Implantation of cardiac resynchronization therapy within the past 3 months or intent to place
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- Patients with a history of heart transplant, currently on the transplant list or with an left ventricular device
- Severe neuropsychiatric impairments
- Non -English or French speaking
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frailty in Community Dwelling Older Adults With Heart Failure
A prospective longitudinal cohort study aimed at measuring frailty and its associated risk factors community dwelling older adults aged 65 years or older.
The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities.
The primary outcome is all-cause mortality at 1-year post enrollment.
Read the detailed description
The overarching research question is as follows: Is frailty predictive of patient-centered outcomes in older adults with heart failure (HF)? Hypotheses regarding this research question are: 1) Frailty is associated with increased 12-month mortality, 2) Frailty is associated with increased 3-month mortality or unplanned hospitalization, 3) Frailty is associated with lower baseline health-related quality of life (HrQOL), and 4) Frailty is associated with worsening HrQOL at 3 months.
There are three specific study objectives. 1) To compare the ability of various frailty measures to predict all-cause mortality, hospitalizations, and HrQOL in patients attending an outpatient HF clinic. 2) To examine the determinants of longitudinal changes in frailty measures over time. Lastly, 3) To examine the clinical and frailty related determinants of fatigue in older adults
A prospective longitudinal cohort study will be conducted at a specialized heart failure (HF) clinic at the Jewish General Hospital (JGH) and Royal Victoria Hospital (RVH). The study aims to measure frailty and its associated risk factors in community dwelling individuals, aged 65 years or older and who have been diagnosed with HF (preserved or reduced ejection fraction) for at least 3 months. The multi-domain geriatric assessment will include questionnaires administered by interview, physical performance tests, body composition analysis using a bioimpedance machine, review of clinically acquired biochemical and imaging tests, and chart review. The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities. Baseline assessment will approximate to 40 minutes of patient contact time while follow up phone interviews at 3 and 12 months will approximate to 20 minutes. Outcome measures such as all-cause mortality, HrQOL, unplanned hospitalization will be assessed at 3 months and 1-year post enrollment.
- Conditions
- Heart Failure, Frail Elderly Syndrome
- Keywords
- frailty, heart failure, mortality, quality of life
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| JGH Cohort | This cohort will not be subjected to any intervention. | |
| RVH Cohort | This cohort will not be subjected to any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality at 12 months
All cause mortality (cardiac and non- cardiac causes) assessed using in hospital chart reviews.
Measured: 12 months
Secondary outcomes (3)
All cause mortality
All cause mortality (cardiac and non- cardiac causes) assessed using in hospital chart reviews.
Measured: 3 months
Unplanned hospitalization at 3 and 12 months
Unplanned hospitalization (In hospital stay for a minimum of 48 hours) assessed using in hospital chart reviews and self-reported hospitalization.
Measured: 3 months and 12 months
Health related quality of life at 3 and 12 months measured using the Short Form Health Survey questionnaire (SF-36)
The sub-scales of the SF-36 include, physical functioning, bodily pain, general health, vitality, social and functioning, mental health.
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
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 Heart FailureStudies 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Jonathan Afilalo, Jewish General Hospital
- Investigators
- Jonathan Afilalo, MD, MSc, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887351
- Sponsor's protocol ID
- MP-05-2019-1682
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Somech J, Joshi A, Mancini R, Chetrit J, Michel C, Sheppard R, Nguyen V, Walker M, Giannetti N, Sharma A, Maghakian D, Laforest E, Afilalo J. Comparison of Questionnaire and Performance-Based Physical Frailty Scales to Predict Survival and Health-Related Quality of Life in Patients With Heart Failure. J Am Heart Assoc. 2023 Mar 21;12(6):e026951. doi: 10.1161/JAHA.122.026951. Epub 2023 Mar 9.
PubMed 36892053
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Community Dwelling Older Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT03887351
- Acronym / sponsor ID
- MP-05-2019-1682
- Conditions
- Heart Failure, Frail Elderly Syndrome
- Keywords
- frailty, heart failure, mortality, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- Apr 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 22 Mar 2019 (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.
A prospective longitudinal cohort study aimed at measuring frailty and its associated risk factors community dwelling older adults aged 65 years or older.
The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities.
The primary outcome is all-cause mortality at 1-year post enrollment.
Detailed description
The overarching research question is as follows: Is frailty predictive of patient-centered outcomes in older adults with heart failure (HF)? Hypotheses regarding this research question are: 1) Frailty is associated with increased 12-month mortality, 2) Frailty is associated with increased 3-month mortality or unplanned hospitalization, 3) Frailty is associated with lower baseline health-related quality of life (HrQOL), and 4) Frailty is associated with worsening HrQOL at 3 months.
There are three specific study objectives. 1) To compare the ability of various frailty measures to predict all-cause mortality, hospitalizations, and HrQOL in patients attending an outpatient HF clinic. 2) To examine the determinants of longitudinal changes in frailty measures over time. Lastly, 3) To examine the clinical and frailty related determinants of fatigue in older adults
A prospective longitudinal cohort study will be conducted at a specialized heart failure (HF) clinic at the Jewish General Hospital (JGH) and Royal Victoria Hospital (RVH). The study aims to measure frailty and its associated risk factors in community dwelling individuals, aged 65 years or older and who have been diagnosed with HF (preserved or reduced ejection fraction) for at least 3 months. The multi-domain geriatric assessment will include questionnaires administered by interview, physical performance tests, body composition analysis using a bioimpedance machine, review of clinically acquired biochemical and imaging tests, and chart review. The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities. Baseline assessment will approximate to 40 minutes of patient contact time while follow up phone interviews at 3 and 12 months will approximate to 20 minutes. Outcome measures such as all-cause mortality, HrQOL, unplanned hospitalization will be assessed at 3 months and 1-year post enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JGH Cohort | – | –This cohort will not be subjected to any intervention. |
| RVH Cohort | – | –This cohort will not be subjected to any intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population is determined using the inclusion and exclusion criteria. Study population will be Montreal based.
Key inclusion criteria (4 listed)
- Community dwelling outpatients
- Aged 65 years or older
- A HF diagnosis with preserved or reduced ejection fraction for at least 3 months
- Agreed to participate and signed an informed consent form
Key exclusion criteria (9 listed)
- Outpatients with a recent hospital admission within 3 months
- Acutely decompensated HF status at the time of their visit
- Received intravenous (IV) diuretics or IV inotropes within 3 months
- A moribund health status with life expectancy less than 3 months
- Scheduled to undergo a major surgical or percutaneous procedure within 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.
Primary outcome
All cause mortality at 12 months
Time frame: 12 months
All cause mortality (cardiac and non- cardiac causes) assessed using in hospital chart reviews.
3 secondary outcomes
All cause mortality
Time frame: 3 months
Unplanned hospitalization at 3 and 12 months
Time frame: 3 months and 12 months
Health related quality of life at 3 and 12 months measured using the Short Form Health Survey questionnaire (SF-36)
Time frame: 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Derived from this study: PubMed 36892053Somech J, Joshi A, Mancini R, Chetrit J, Michel C, Sheppard R, Nguyen V, Walker M, Giannetti N, Sharma A, Maghakian D, Laforest E, Afilalo J. Comparison of Questionnaire and Performance-Based Physical Frailty Scales to Predict Survival and Health-Related Quality of Life in Patients With Heart Failure. J Am Heart Assoc. 2023 Mar 21;12(6):e026951. doi: 10.1161/JAHA.122.026951. Epub 2023 Mar 9.
- 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.
Jonathan Afilalo, MD, MSc principal investigator
Jewish General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Frail Elderly Syndrome, run by Jewish General Hospital.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Trnkus, MSc (5143408222 ext. 28692, amanda.trnkus@ladydavis.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality at 12 months (time frame: 12 months). 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 NCT03887351, 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 22 Mar 2019; AzTrials last refreshed its copy on 28 Oct 2026.