Body Composition in Systemic Amyloidosis

Completed

• Conditions: Amyloidosis
• Interventions: Other: Dietary advice

• Registration Number: NCT02111538
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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 Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amyloidosis	Dietary advice	Consecutive adult patients affected by systemic immunoglobulin light-chain (AL) amyloidosis

Primary Outcome Measures

Name	Time	Method
Mortality	12 months	All-cause mortality at 12 months since baseline assessment

Secondary Outcome Measures

Name	Time	Method
Quality of life	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	12 months	Association between phase angle and its changes at 6 months and mortality at 12 months.

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy