NCT06907186Recruiting
An 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
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Hereditary transthyretin amyloidosis (ATTRv) is a genetic, progressive and disabling disease that affects multiple organs and severely compromises the quality of life of patients and their families. A holistic approach is essential, which, in addition to early diagnosis and clinical management, includes psychological support to address the emotional and psychosocial impact of the disease. Although specific interventions for mental well-being are recommended, studies evaluating support tools for patients with ATTRv cardiomyopathy and their caregivers are lacking.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 26 Mar 2025
- Start date
- 24 May 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Amyloidosis
- NCT number
- NCT06907186
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 24 May 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo, Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.