ClinicalTrials.gov record NCT06907186

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old and older

SexAll

LocationItaly

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-arm pilot study offers a 12-month structured psychological support program for people affected by hereditary transthyretin amyloidosis with cardiomyopathy, their caregivers, and presymptomatic carriers. Support is provided by monthly interviews, in person or remotely. The study mainly measures whether the program is feasible and acceptable and collects early data on anxiety and depression.

What it is studying. Whether a monthly, structured psychological support program can be delivered and accepted by patients, caregivers, and presymptomatic carriers, and whether it is associated with changes in anxiety and depression at 6 and 12 months.

What the researchers hope to learn. To evaluate feasibility (measured by the percentage of interviews attended, target ≥80%), to measure acceptance (how many eligible people accept support at baseline), and to gather preliminary data on anxiety and depression at 6 and 12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other: Psychological Support

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The overall objective of the study is to evaluate the feasibility, acceptance and preliminary efficacy data of a structured psychological support program for patients, caregivers and presymptomatic carriers in hereditary transthyretin amyloidosis (ATTRv) with cardiomyopathy. The primary objective is to evaluate the feasibility of a psychological support program for patients, caregivers and presymptomatic carriers. The co-primary objective is to evaluate the acceptance by patients of the proposed psychological support program.Key secondary objective: Evaluate the effects of the psychological support program on the levels of anxiety and depression in patients and presymptomatic carriers of ATTRv during the psychological support pathway (at 6 months) and at the end (at 12 months);

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part in a structured psychological support program made of monthly psychological support interviews delivered in person or remotely. Participants will be asked to accept the support, attend regular sessions over the study period, and complete assessments of anxiety and depression during the program (including at about 6 months and at 12 months). No invasive medical procedures are listed in the record.

How the study is structured. Interventional, single-group (no control group) pilot study. Participants receive a systematic series of monthly psychological support interviews, delivered in person or remotely, and are followed for outcomes over 12 months. The study is not masked.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 24, 2024
Primary completion: Dec 31, 2025 (estimated)
Study completion: Dec 31, 2025 (estimated)
Target enrollment: 150 participants (estimated)
Last updated on registry: Apr 6, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Principal investigator: Laura Obici, Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Laura Obici, MD 📞 +390382502983 ✉ l.obici@smatteo.pv.it

Participating sites (1)

Fondazione IRCCS Policlinico San Matteo, Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta ComplessitàRecruiting
Pavia, 27100 · Italy
- Laura Obici · +390382502983 · l.obici@smatteo.pv.it

Terms used on this page · explanations by MedicalUpdates.ai

Informed Consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
primary objective: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
secondary objective: An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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