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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

mHealth
Procedure/Surgery
Follow-up and treatment of patients in the mHealth arm will be based on a comprehensive solution for the care and monitoring of chronic patients, modelled and tested in chronic HF patients. This is the PIRENe platform, previously described and evaluated in HF patients. It is a digital solution, external to the centre's information systems (external platform). However, it has some special features in its design in terms of remote monitoring, educational tools, among others, expressly conceived and designed for patients with ATTR-CM. This platform allows the provision of multichannel service and monitoring of patients through: 1. Patient monitoring of: Biometric data and symptom report. 2. Generation and management of warning alarms notified to the professionals assigned to each patient in case one of the following situations occurs. 3. Follow-up via videoconference.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: mHealthExperimental treatment 1 intervention

Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).

changes in patient-reported outcomes (PROMs) such as self-care European Heart Failure Self-Care Behaviour Scale) between patients followed and monitored using the mHealth-based digital tool (mHealth) and those in standard follow-up (usual care \[UC\]).

Time frame