Psychological support program for patients with hereditary transthyretin amyloidosis
Official title: A Single-arm Interventional Pilot Study to Investigate the Feasibility and Acceptance of a Structured Psychological Support Program for Patients, Caregivers, and Presymptomatic Carriers in Hereditary Transthyretin Amyloidosis With Cardiomyopathy
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06907186 · Data updated 2026-11-12
This study is testing a new psychological support program for patients and their families dealing with hereditary transthyretin amyloidosis to see if it helps reduce feelings of anxiety and depression over a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Status | Recruiting |
| Started | May 24, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | April 6, 2025 |
| Trial ID | NCT06907186 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are patients, presymptomatic carriers, or caregivers involved with the Amyloidosis Center in Pavia.
✕Probably not a fit
Patients diagnosed with other types of amyloidosis will not benefit from this specific psychological support program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates a structured psychological support program aimed at patients, caregivers, and presymptomatic carriers of hereditary transthyretin amyloidosis (ATTRv) with cardiomyopathy. The primary focus is to assess the feasibility and acceptance of this program, while also measuring its impact on anxiety and depression levels over a 12-month period. Participants will receive psychological support tailored to address the emotional and psychosocial challenges associated with this progressive disease. The study is conducted at the Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental well-being and quality of life for patients and their families affected by hereditary transthyretin amyloidosis.
How similar studies have gone: While specific studies on psychological support for ATTRv patients are limited, similar approaches in other chronic conditions have shown positive outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age of 18 years; * Fluent in Italian; * Patient, presymptomatic carrier or ATTRv caregiver, in charge of UOC General Medicine 2 - Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia; * Signing of the specific Informed Consent Exclusion Criteria: * Subjects who, although belonging to UOC General Medicine 2 - Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia - present a diagnosis of another type of amyloidosis.
Where it's running
-
Fondazione IRCCS Policlinico San Matteo, Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità
Pavia, Italy Recruiting
Study contacts
- Study coordinator: Laura Obici, MD
- Email: l.obici@smatteo.pv.it
- Phone: +390382502983
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.