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

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Unknown status
CT.gov ID
NCT03153774
Collaborator
(none)
300
1
2
48.9
6.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Assessment of sarcopenia prevalence
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open
Primary Purpose:
Diagnostic
Official Title:
Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation
Actual Study Start Date :
Nov 3, 2014
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Bioimpedance analysis data [at day 1]

    Fat-free mass and body fat mass will be combined to report BMI in Kg/m2

  2. Short physical performance battery [at day 1]

    Balance test, 4-min walking test, 5 times getting-up test

  3. Handgrip test [at day 1]

Secondary Outcome Measures

  1. Blood draw for serum creatinine in umol/L [at day 1]

    Measure of inflammation

  2. CRP in mg/L [at day 1]

    Measure of inflammation

  3. platelets in Giga/L [at day 1]

    Measure of inflammation

  4. complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L) [at day 1]

    Measure of inflammation

  5. urea in mmol/L [at day 1]

    Measure of inflammation

  6. albumin in g/L [at day 1]

    Measure of inflammation

  7. NT-ProBNP in ng/L [at day 1]

    Measure of inflammation

  8. Electrocardiogram [at day 1]

    Parameter which may interfere with sarcopenia

  9. Trans-thoracic echography [at day 1]

    Parameter which may interfere with sarcopenia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Clermont-Ferrand Clermont-Ferrand Auvergne France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT03153774
Other Study ID Numbers:
  • CHU-324
  • 2014-A00938-39
First Posted:
May 15, 2017
Last Update Posted:
May 15, 2017
Last Verified:
May 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 15, 2017