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Can a smartphone app keep heart patients out of the hospital? new study aims to find out.

NCT ID NCT07557147

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study looks at whether a digital tool called Luscii is practical and acceptable for people with a rare heart condition called ATTR-CM. About 60 adults in Austria, Germany, and Italy will use a smartphone app and home devices to share health information with their care team. The goal is to see if remote monitoring can help catch problems early and improve communication between clinic visits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Eligible participants will be invited by their treating physician and, after providing informed consent, will be observed for approx. 12 months. Patients with an established diagnosis of either wild-type or variant ATTR-CM can be enrolled. Evidence of assessment of all eligibility criteria by the physician or a delegate, as well as enrolment of a participant in the study should be documented in the participant medical records. Medical professionals who are directly involved in the participants' treatment and who have access to and will review the Luscii-captured data for routine care are asked to complete the study-specific questionnaires/forms.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For patients: * Adult (≥18 years at the date of signing the informed consent form (ICF)). * Diagnosis of either wild-type or variant ATTR-CM. * Treatment with a drug approved for ATTR-CM, including newly prescribed therapy at the initial visit. * Signed ICF. * Access to and basic ability to use a personal smartphone with internet connectivity sufficient to install and operate the Luscii contact application. For medical professionals: * Directly involved in the treatment or clinical management of the enrolled ATTR-CM participants and having access to and reviewing the Luscii-captured data for routine care. * Agreement to ICF within the EDC system for the purpose of using Luscii or to complete the HCP Experience Questionnaire. Exclusion Criteria: For patients: * Participation in an investigational program with interventions outside of routine clinical practice. * Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative. For medical professionals: * Any current affiliation with Luscii, Bayer, or any of their affiliates.

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Conditions

The condition(s) this trial relates to.

wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin amyloid cardiomyopathy (attr-CM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Policlinico San Matteo di Pavia

    Pavia, 27100, Italy

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

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Other studies related to the condition(s) this trial covers.