Amyloidosis
Conditions
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.
Interventions
OTHERDietary advice
Standard dietary advice are provided to all patients at baseline and during the follow-up to all requiring or asking for
Sponsors
Akern Srl
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 12 months | All-cause mortality at 12 months since baseline assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed