Status:
NOT_YET_RECRUITING
EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Institut d'Investigació Biomèdica de Bellvitge
Conditions:
Heart Failure
Amyloid Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-report...
Detailed Description
Background and Rationale: Early diagnosis as well as optimal care of transthyretin-associated amyloidosis (ATTR)-cardiomyopathy (CM) is crucial to improve the outcome of these patients. In order to p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06499064
Start Date
December 1 2024
End Date
March 15 2026
Last Update
October 23 2024
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