BIVAmyloid: Body Composition in Systemic Amyloidosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Mortality [12 months]
All-cause mortality at 12 months since baseline assessment
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of systemic immunoglobulin light-chain (AL) amyloidosis
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Written informed consent
Exclusion Criteria:
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Age <18 years
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Ongoing artificial nutrition
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Unavailability to planned measurements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | 27100 |
Sponsors and Collaborators
- IRCCS Policlinico S. Matteo
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Norman K, Stobäus 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. Review.
- 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.
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