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Body Composition in Systemic Amyloidosis (BIVAmyloid)

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ClinicalTrials.gov Identifier: NCT02111538
Recruitment Status : Recruiting
First Posted : April 11, 2014
Last Update Posted : December 4, 2017
Akern Srl
Information provided by (Responsible Party):
Riccardo Caccialanza, IRCCS Policlinico S. Matteo

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
Amyloidosis Other: Dietary advice

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Value of Phase Angle in Systemic Immunoglobulin Light-chain (AL) Amyloidosis
Study Start Date : February 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Mortality [ Time Frame: 12 months ]
    All-cause mortality at 12 months since baseline assessment

Secondary Outcome Measures :
  1. 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.

  2. Mortality [ Time Frame: 12 months ]
    Association between phase angle and its changes at 6 months and mortality at 12 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111538

Contact: Riccardo Caccialanza, MD 00390382501615 r.caccialanza@smatteo.pv.it

Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Riccardo Caccialanza, MD         
Sub-Investigator: Emanuele Cereda, MD, PhD         
Sub-Investigator: Giovanni Palladini, MD, PhD         
Sub-Investigator: Giampaolo Merlini, MD, PhD         
Sub-Investigator: Chiara Bonardi, RD         
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Akern Srl
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


Responsible Party: Riccardo Caccialanza, Physician, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02111538     History of Changes
Other Study ID Numbers: 20130026923
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Proteostasis Deficiencies
Metabolic Diseases
Immunoglobulin Light Chains
Bence Jones Protein
Immunologic Factors
Physiological Effects of Drugs