Body Composition in Systemic Amyloidosis (BIVAmyloid)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Amyloidosis

Treatments: Other: Dietary advice

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02111538

20130026923

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of systemic immunoglobulin light-chain (AL) amyloidosis
• Written informed consent

Exclusion criteria

• Age <18 years
• Ongoing artificial nutrition
• Unavailability to planned measurements

Trial design

127 participants in 1 patient group

Amyloidosis

Description:

Consecutive adult patients affected by systemic immunoglobulin light-chain (AL) amyloidosis

Treatment:

Other: Dietary advice