NCT03153774

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

May 5, 2017

Last Update Submit

May 12, 2017

Conditions

SarcopeniaChronic Heart Failure

Keywords

SarcopeniaHeart failure (HF)The trans aortic valvular implantation (TAVI)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Blood draw for serum creatinine in umol/L

    at day 1

  • CRP in mg/L

    at day 1

  • platelets in Giga/L

    at day 1

  • complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)

    at day 1

  • urea in mmol/L

    at day 1

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Diagnostic Test: Assessment of sarcopenia prevalence

Interventions

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

Heart failure patientsTAVI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35871922DERIVED

  • 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.

    PMID: 33483182DERIVED

MeSH Terms

Conditions

SarcopeniaHeart Failure

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsHeart DiseasesCardiovascular Diseases

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferand.fr

Romain ESCHALIER, PhD

CONTACT

0033 473 751 410reschalier@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 15, 2017

Study Start

November 3, 2014

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

FR(1)