Body Composition in Systemic Amyloidosis (BIVAmyloid)

April 29, 2025 updated by: Riccardo Caccialanza, Fondazione IRCCS Policlinico San Matteo di Pavia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive adult patients affected by systemic immunoglobulin light-chain (AL) amyloidosis attending the Amyloidosis Research and Treatment Center (Fondazione IRCCS Policlinico San Matteo)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Amyloidosis
Consecutive adult patients affected by systemic immunoglobulin light-chain (AL) amyloidosis
Other: Dietary advice
Standard dietary advice are provided to all patients at baseline and during the follow-up to all requiring or asking for

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months
All-cause mortality at 12 months since baseline assessment
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Mortality
Time Frame: 12 months
Association between phase angle and its changes at 6 months and mortality at 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborators

Akern Srl

Investigators

  • Principal Investigator: Riccardo Caccialanza, MD, Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
  • Study Director: Giampaolo Merlini, MD, PhD, Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimated)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130026923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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