EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM) (NCT06499064) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)
50 participantsStarted 2024-12-01
Plain-language summary
Unicenter, proof-of-concept, prospective, randomised, controlled, open-label and blinded end-point adjudication trial to assess the effect on patient-reported outcomes measures (PROMs), patient-reported experience measures (PREMs) and clinical events of a mHealth-based comprehensive management program for patients with chronic heart failure (HF) due to transthyretin-associated amyloidosis (ATTR)-cardiomyopathy (CM) by means of remote daily telemonitoring of signs and symptoms and remote structured follow-up using videoconference.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old
* HF diagnosis according to European Society of Cardiology (ESC)
* Patients with a HF decompensation in the last 12 months
* Confirmed diagnosis of ATTR-CM (ATTRv or ATTRwt)
* Written informed consent
Exclusion Criteria:
* Age\<18 years old
* Participation in another clinical trial
* Moderate or severe cognitive impairment without a competent caregiver
* Lack of social support
* Institutionalized patients
* Life expectancy less than 1 year (excluding HF)
* Institutional-based or end-of-life care
* Serious psychiatric illness
* Planned cardiac surgery
* Planned heart transplantation or left ventricular assist device (LVAD) implant
* Patients in haemodialysis program
* The patient is unable or unwilling to give the informed consent to participate
* The patient is considered an unsuitable candidate for this study according to the decision of the local investigator
* Unstable patients with signs of fluid overload or low cardiac output
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
Timeframe: Six months after inclusion of the patient
2
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
Timeframe: Six months after inclusion of the patient