Clinical Trial: Body Composition in Systemic Amyloidosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prognostic Value of Phase Angle in Systemic Immunoglobulin Light-chain (AL) Amyloidosis

Brief Summary: Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the prognosis predominantly depend on the presence and severity of cardiac involvement, it was shown that malnutrition is an independent predictor of survival and quality of life. However, the assessment of nutritional status by common indices based on anthropometry is not always feasible and accurate due to reduced performance status and/or the presence of fluid imbalances (for example edema and ascites). Several recent studies have demonstrated the prognostic value of the phase angle. Moreover, the value is supported by its applicability to patients who are bedridden or present alterations in the state of hydration.

Detailed Summary:
Sponsor: IRCCS Policlinico S. Matteo

Current Primary Outcome: Mortality [ Time Frame: 12 months ]

All-cause mortality at 12 months since baseline assessment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: 6 months ]
    Association between phase angle and quality of life at baseline and 6 months. Association between changes in phase angle and in quality of life at 6 months.
  • Mortality [ Time Frame: 12 months ]
    Association between phase angle and its changes at 6 months and mortality at 12 months.


Original Secondary Outcome: Same as current

Information By: IRCCS Policlinico S. Matteo

Dates:
Date Received: February 24, 2014
Date Started: February 2014
Date Completion: December 2017
Last Updated: August 29, 2016
Last Verified: August 2016