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Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before TAVI (PRESAR-HF)

Primary Purpose

Sarcopenia, Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of sarcopenia prevalence
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcopenia focused on measuring Sarcopenia, Heart failure (HF), The trans aortic valvular implantation (TAVI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Heart failure patients

TAVI patients

Arm Description

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 main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.

Outcomes

Primary Outcome Measures

Bioimpedance analysis data
Fat-free mass and body fat mass will be combined to report BMI in Kg/m2
Short physical performance battery
Balance test, 4-min walking test, 5 times getting-up test
Handgrip test

Secondary Outcome Measures

Blood draw for serum creatinine in umol/L
Measure of inflammation
CRP in mg/L
Measure of inflammation
platelets in Giga/L
Measure of inflammation
complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)
Measure of inflammation
urea in mmol/L
Measure of inflammation
albumin in g/L
Measure of inflammation
NT-ProBNP in ng/L
Measure of inflammation
Electrocardiogram
Parameter which may interfere with sarcopenia
Trans-thoracic echography
Parameter which may interfere with sarcopenia

Full Information

First Posted
May 5, 2017
Last Updated
May 12, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03153774
Brief Title
Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before TAVI
Acronym
PRESAR-HF
Official Title
Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2014 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Chronic Heart Failure
Keywords
Sarcopenia, Heart failure (HF), The trans aortic valvular implantation (TAVI)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart failure patients
Arm Type
Experimental
Arm Description
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.
Arm Title
TAVI patients
Arm Type
Experimental
Arm Description
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of sarcopenia prevalence
Intervention Description
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
Primary Outcome Measure Information:
Title
Bioimpedance analysis data
Description
Fat-free mass and body fat mass will be combined to report BMI in Kg/m2
Time Frame
at day 1
Title
Short physical performance battery
Description
Balance test, 4-min walking test, 5 times getting-up test
Time Frame
at day 1
Title
Handgrip test
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Blood draw for serum creatinine in umol/L
Description
Measure of inflammation
Time Frame
at day 1
Title
CRP in mg/L
Description
Measure of inflammation
Time Frame
at day 1
Title
platelets in Giga/L
Description
Measure of inflammation
Time Frame
at day 1
Title
complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)
Description
Measure of inflammation
Time Frame
at day 1
Title
urea in mmol/L
Description
Measure of inflammation
Time Frame
at day 1
Title
albumin in g/L
Description
Measure of inflammation
Time Frame
at day 1
Title
NT-ProBNP in ng/L
Description
Measure of inflammation
Time Frame
at day 1
Title
Electrocardiogram
Description
Parameter which may interfere with sarcopenia
Time Frame
at day 1
Title
Trans-thoracic echography
Description
Parameter which may interfere with sarcopenia
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Romain ESCHALIER, PhD
Phone
0033 473 751 410
Email
reschalier@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Romain ESCHALIER
Phone
0033 473 751 410
Email
reschalier@chu-clermontferrand.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
35871922
Citation
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.
Results Reference
derived
PubMed Identifier
33483182
Citation
Eschalier 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.
Results Reference
derived

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Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before TAVI

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