SarcopeniaPRESAR-HFNCT03153774
Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before TAVI
A study testing Assessment of sarcopenia prevalence in people with Sarcopenia and Chronic Heart Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation. The loss of muscle mass in chronic heart failure patients is a prognostic factor for sarcopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Chronic Heart Failure
- What is being tested?
- Assessment of sarcopenia prevalence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2014to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients (>18 years)
- Men or women
- Hospitalized in pre- trans aortic valvular implantation assessment in the cardiology department of the university hospital centre of Clermont-Ferrand or
- Patients with chronic heart failure in charge in the hospital of Clermont-Ferrand or convalescence in the pneumocardiological clinic of Durtol
Who cannot join
- Patient not affiliated to social security
- Inability to understand the information consent letter
- Not having signed informed consent
- Has a mental or legal incapacitation and is unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Romain ESCHALIER, 0033 473 751 410, reschalier@chu-clermontferrand.fr
About this study
Official title: Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.
The loss of muscle mass in chronic heart failure patients is a prognostic factor for sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better management.
Read the detailed description
Age-related muscle loss, termed sarcopenia, affects 10% of elderly subjects aged 60-70 years and more than 30% above the age of 80. The concept of sarcopenia has been supported by the recent findings of muscular atrophy which was related to the decrease of protein synthesis because of the "anabolic resistance", affecting the muscular fibers type II. In fact, sarcopenia could be a consequence of chronic disease and not only an issue in the elderly people. The diagnosis is assessed by the weak muscle mass and the muscle strength and function. A description of these muscle parameters has been described in a study of 200 patients with NYHA class II-III and showed that 19,5 % have a decrease in muscle mass. They also showed that these patients have a lower functional ability. These findings prompted us to investigate the prevalence of sarcopenia in chronic heart failure subjects for a better management of these patients.
- Conditions
- Sarcopenia, Chronic Heart Failure
- Being tested
- Assessment of sarcopenia prevalence
- Keywords
- Sarcopenia, Heart failure (HF), The trans aortic valvular implantation (TAVI)
- Medical subject headings
- Sarcopenia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sarcopenia prevalenceDiagnostic test
Handgrip test, Bioimpedance analysis (Bodystat), 6-min walking test, Short physical performance battery (balance test, 4-min walking test, 5 times getting-up test), Biological markers test, Trans-thoracic echography, Electrocardiogram 12 leads, Palm gripping test
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients | Experimental | The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation. Receives: Diagnostic Test: Assessment of sarcopenia prevalence |
| TAVI patients | Experimental | The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation. Receives: Diagnostic Test: Assessment of sarcopenia prevalence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioimpedance analysis data
Fat-free mass and body fat mass will be combined to report BMI in Kg/m2
Measured: at day 1
Short physical performance battery
Balance test, 4-min walking test, 5 times getting-up test
Measured: at day 1
Handgrip test
Measured: at day 1
Secondary outcomes (9)
Blood draw for serum creatinine in umol/L
Measure of inflammation
Measured: at day 1
CRP in mg/L
Measure of inflammation
Measured: at day 1
platelets in Giga/L
Measure of inflammation
Measured: at day 1
complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)
Measure of inflammation
Measured: at day 1
urea in mmol/L
Measure of inflammation
Measured: at day 1
albumin in g/L
Measure of inflammation
Measured: at day 1
NT-ProBNP in ng/L
Measure of inflammation
Measured: at day 1
Electrocardiogram
Parameter which may interfere with sarcopenia
Measured: at day 1
Trans-thoracic echography
Parameter which may interfere with sarcopenia
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start3 Nov 2014
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153774
- Sponsor's protocol ID
- CHU-324
- Other IDs
- 2014-A00938-39
- Acronym
- PRESAR-HF
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blanquet M, Massoulie G, Boirie Y, Guiguet-Auclair C, Mulliez A, Anker S, Boiteux MD, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Rossignol P, Clerfond G, Eschalier R. Handgrip strength to screen early-onset sarcopenia in heart failure. Clin Nutr ESPEN. 2022 Aug;50:183-190. doi: 10.1016/j.clnesp.2022.05.019. Epub 2022 Jun 6.
PubMed 35871922Eschalier R, Massoullie G, Boirie Y, Blanquet M, Mulliez A, Tartiere PL, Anker S, D'Agrosa Boiteux MC, Richard R, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Stolt P, Rossignol P, Clerfond G. Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact. Clin Nutr. 2021 Jun;40(6):4490-4499. doi: 10.1016/j.clnu.2020.12.033. Epub 2021 Jan 9.
PubMed 33483182
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT03153774
- Acronym / sponsor ID
- PRESAR-HF / CHU-324
- Conditions
- Sarcopenia, Chronic Heart Failure
- Keywords
- Sarcopenia, Heart failure (HF), The trans aortic valvular implantation (TAVI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 May 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.
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.
The loss of muscle mass in chronic heart failure patients is a prognostic factor for sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better management.
Detailed description
Age-related muscle loss, termed sarcopenia, affects 10% of elderly subjects aged 60-70 years and more than 30% above the age of 80. The concept of sarcopenia has been supported by the recent findings of muscular atrophy which was related to the decrease of protein synthesis because of the "anabolic resistance", affecting the muscular fibers type II. In fact, sarcopenia could be a consequence of chronic disease and not only an issue in the elderly people. The diagnosis is assessed by the weak muscle mass and the muscle strength and function. A description of these muscle parameters has been described in a study of 200 patients with NYHA class II-III and showed that 19,5 % have a decrease in muscle mass. They also showed that these patients have a lower functional ability. These findings prompted us to investigate the prevalence of sarcopenia in chronic heart failure subjects for a better management of these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | Experimental | Diagnostic Test: Assessment of sarcopenia prevalenceThe main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation. |
| TAVI patients | Experimental | Diagnostic Test: Assessment of sarcopenia prevalenceThe main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patients (>18 years)
- Men or women
- Hospitalized in pre- trans aortic valvular implantation assessment in the cardiology department of the university hospital centre of Clermont-Ferrand or
- Patients with chronic heart failure in charge in the hospital of Clermont-Ferrand or convalescence in the pneumocardiological clinic of Durtol
Key exclusion criteria (4 listed)
- Patient not affiliated to social security
- Inability to understand the information consent letter
- Not having signed informed consent
- Has a mental or legal incapacitation and is unable to provide informed consent.
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 |
|---|---|---|
| Assessment of sarcopenia prevalenceHandgrip test, Bioimpedance analysis (Bodystat), 6-min walking test, Short physical performance battery (balance test, 4-min walking test, 5 times getting-up test), Biological markers test, Trans-thoracic echography, Electrocardiogram 12 leads, Palm gripping test | Diagnostic test | Heart failure patients, TAVI patients |
Primary outcome
Bioimpedance analysis data
Time frame: at day 1
Fat-free mass and body fat mass will be combined to report BMI in Kg/m2
Short physical performance battery
Time frame: at day 1
Balance test, 4-min walking test, 5 times getting-up test
Handgrip test
Time frame: at day 1
9 secondary outcomes
Blood draw for serum creatinine in umol/L
Time frame: at day 1
CRP in mg/L
Time frame: at day 1
platelets in Giga/L
Time frame: at day 1
complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)
Time frame: at day 1
urea in mmol/L
Time frame: at day 1
albumin in g/L
Time frame: at day 1
NT-ProBNP in ng/L
Time frame: at day 1
Electrocardiogram
Time frame: at day 1
Trans-thoracic echography
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Derived from this study: PubMed 35871922Blanquet M, Massoulie G, Boirie Y, Guiguet-Auclair C, Mulliez A, Anker S, Boiteux MD, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Rossignol P, Clerfond G, Eschalier R. Handgrip strength to screen early-onset sarcopenia in heart failure. Clin Nutr ESPEN. 2022 Aug;50:183-190. doi: 10.1016/j.clnesp.2022.05.019. Epub 2022 Jun 6.
- Derived from this study: PubMed 33483182Eschalier R, Massoullie G, Boirie Y, Blanquet M, Mulliez A, Tartiere PL, Anker S, D'Agrosa Boiteux MC, Richard R, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Stolt P, Rossignol P, Clerfond G. Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact. Clin Nutr. 2021 Jun;40(6):4490-4499. doi: 10.1016/j.clnu.2020.12.033. Epub 2021 Jan 9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of sarcopenia prevalence in people with Sarcopenia and Chronic Heart Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 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 15 May 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioimpedance analysis data (time frame: at day 1). The study lists 3 primary outcomes in all. 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 NCT03153774, which also lists 2 linked publications.
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 15 May 2017.