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OpenTrials
Completed

NCT Number: NCT02111538

Body Composition in Systemic 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.

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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Advice

Other

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

Primary outcomes

  1. Mortality

    Time frame: 12 months

    All-cause mortality at 12 months since baseline assessment

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Akern Srl

Registry information

Official study title

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

Acronym: BIVAmyloid

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2014
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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