EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)

ConditionsHeart Failure Amyloid Cardiomyopathy ATTR Amyloidosis Wild Type ATTR Gene Mutation

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHospital Universitari de Bellvitge

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Age<18 years old

Participation in another clinical trial

Moderate or severe cognitive impairment without a competent caregiver

Lack of social support

Trial design

Treatments tested in this trial

mHealth

Treatment groups

50 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Hospital Universitari de Bellvitge

Lead sponsor

Institut d'Investigació Biomèdica de Bellvitge

Collaborator

Source ClinicalTrials.gov