Body Composition in Systemic Amyloidosis

NCT02111538 | Completed DMC

• 1 other identifier: 20130026923
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Mortality

  All-cause mortality at 12 months since baseline assessment

  12 months

Secondary Outcomes (2)

• Quality of life

  6 months

• Mortality

  12 months

Study Arms (1)

Amyloidosis

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

Other: Dietary advice

Interventions

Dietary advice OTHER

Standard dietary advice are provided to all patients at baseline and during the follow-up to all requiring or asking for

Amyloidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Akern Srl: collaborator

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (6)

• Caccialanza R, Palladini G, Klersy C, Cereda E, Bonardi C, Cameletti B, Quarleri L, Montagna E, Foli A, Milani P, Lavatelli F, Marena C, Merlini G. Malnutrition at diagnosis predicts mortality in patients with systemic immunoglobulin light-chain amyloidosis independently of cardiac stage and response to treatment. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):891-4. doi: 10.1177/0148607113501328. Epub 2013 Sep 26.

  PMID: 24072737 BACKGROUND

• Caccialanza R, Palladini G, Klersy C, Cereda E, Bonardi C, Cameletti B, Montagna E, Russo P, Foli A, Milani P, Lavatelli F, Merlini G. Nutritional status independently affects quality of life of patients with systemic immunoglobulin light-chain (AL) amyloidosis. Ann Hematol. 2012 Mar;91(3):399-406. doi: 10.1007/s00277-011-1309-x. Epub 2011 Aug 9.

  PMID: 21826471 BACKGROUND

• Caccialanza R, Palladini G, Klersy C, Cena H, Vagia C, Cameletti B, Russo P, Lavatelli F, Merlini G. Nutritional status of outpatients with systemic immunoglobulin light-chain amyloidosis 1. Am J Clin Nutr. 2006 Feb;83(2):350-4. doi: 10.1093/ajcn/83.2.350.

  PMID: 16469994 BACKGROUND

• Sattianayagam PT, Lane T, Fox Z, Petrie A, Gibbs SD, Pinney JH, Risom SS, Rowczenio DM, Wechalekar AD, Lachmann HJ, Gilbertson JA, Hawkins PN, Gillmore JD. A prospective study of nutritional status in immunoglobulin light chain amyloidosis. Haematologica. 2013 Jan;98(1):136-40. doi: 10.3324/haematol.2012.070359. Epub 2012 Sep 14.

  PMID: 22983575 BACKGROUND

• Norman K, Stobaus N, Pirlich M, Bosy-Westphal A. Bioelectrical phase angle and impedance vector analysis--clinical relevance and applicability of impedance parameters. Clin Nutr. 2012 Dec;31(6):854-61. doi: 10.1016/j.clnu.2012.05.008. Epub 2012 Jun 12.

  PMID: 22698802 BACKGROUND

• Caccialanza R, Cereda E, Klersy C, Milani P, Cappello S, Martinelli V, Turri A, Basset M, Borioli V, Nuvolone M, Caraccia M, Lavatelli F, Masi S, Lobascio F, Foli A, Merlini G, Palladini G. Bioelectrical impedance vector analysis-derived phase angle predicts survival in patients with systemic immunoglobulin light-chain amyloidosis. Amyloid. 2020 Sep;27(3):168-173. doi: 10.1080/13506129.2020.1737004. Epub 2020 Mar 26.

  PMID: 32212933 DERIVED

MeSH Terms

Conditions

Amyloidosis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Riccardo Caccialanza, MD

  Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

• Giampaolo Merlini, MD, PhD

  Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: April 11, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

IT (1)