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

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.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia; Chronic Heart Failure
• Intervention / Treatment: Diagnostic test: Assessment of sarcopenia prevalence

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Recruiting
      • CHU Clermont-Ferrand
      • Contact: Romain ESCHALIER; Phone Number: 0033 473 751 410; Email: reschalier@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart failure patients; The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.	Diagnostic test: Assessment of sarcopenia prevalence; 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
Experimental: TAVI patients; The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.	Diagnostic test: Assessment of sarcopenia prevalence; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioimpedance analysis data	Fat-free mass and body fat mass will be combined to report BMI in Kg/m2	at day 1
Short physical performance battery	Balance test, 4-min walking test, 5 times getting-up test	at day 1
Handgrip test		at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood draw for serum creatinine in umol/L	Measure of inflammation	at day 1
CRP in mg/L	Measure of inflammation	at day 1
platelets in Giga/L	Measure of inflammation	at day 1
complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)	Measure of inflammation	at day 1
urea in mmol/L	Measure of inflammation	at day 1
albumin in g/L	Measure of inflammation	at day 1
NT-ProBNP in ng/L	Measure of inflammation	at day 1
Electrocardiogram	Parameter which may interfere with sarcopenia	at day 1
Trans-thoracic echography	Parameter which may interfere with sarcopenia	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2014
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Sarcopenia; Heart failure (HF); The trans aortic valvular implantation (TAVI)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Heart Failure; Sarcopenia
• Other Study ID Numbers: CHU-324; 2014-A00938-39 (Other Identifier: 2014-A00938-39)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No