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

Sarcopenia Clinical Trial

— PRESAR-HF  

Official title:

Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153774
• Other study ID #: CHU-324
• Secondary ID: 2014-A00938-39
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 12, 2017
• Start date: November 3, 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The purpose was to identify in these patients signs of sarcopenia for a better management.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioimpedance analysis data	Fat-free mass and body fat mass will be combined to report BMI in Kg/m2	at day 1
Primary	Short physical performance battery	Balance test, 4-min walking test, 5 times getting-up test	at day 1
Primary	Handgrip test		at day 1
Secondary	Blood draw for serum creatinine in umol/L	Measure of inflammation	at day 1
Secondary	CRP in mg/L	Measure of inflammation	at day 1
Secondary	platelets in Giga/L	Measure of inflammation	at day 1
Secondary	complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)	Measure of inflammation	at day 1
Secondary	urea in mmol/L	Measure of inflammation	at day 1
Secondary	albumin in g/L	Measure of inflammation	at day 1
Secondary	NT-ProBNP in ng/L	Measure of inflammation	at day 1
Secondary	Electrocardiogram	Parameter which may interfere with sarcopenia	at day 1
Secondary	Trans-thoracic echography	Parameter which may interfere with sarcopenia	at day 1