Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Unita Sanitaria Locale di Piacenza
About this trial
This is a single-center, randomized, open-label, no-profit interventional trial designed to evaluate the effectiveness of a telemedicine-based follow-up strategy compared with standard ambulatory care in patients with newly diagnosed heart failure with reduced ejection fraction (HFrEF). The study aims to determine whether telemedicine-guided management improves the optimization of guideline-directed medical therapy (GDMT), measured as change in GDMT score at 6 months. Patients will be randomized to either a telemedicine group, involving remote multiparametric monitoring and structured teleconsultations, or a standard-of-care group based on conventional in-person follow-up. Secondary objectives include the assessment of safety, treatment adherence, quality of life, and heart failure-related urgent visits, emergency department access, and hospitalizations. This study will provide evidence on the role of telemedicine in facilitating early and effective optimization of heart failure therapy and improving clinical management in a real-world setting.
Eligibility criteria
Qualifiers
Provision of written informed consent.
Age ≥18 years.
Recent diagnosis of HFrEF, defined according to ESC criteria, established in either an inpatient or outpatient setting.
No prior initiation of GDMT for HF at the time of enrollment, or treatment limited to a single agent with potential disease-modifying effects prescribed for a different clinical indication.
Disqualifiers
Ongoing treatment with two or more guideline-directed heart failure medications at the time of HFrEF diagnosis
Presence of severe comorbidities or clinical instability requiring prolonged or continuous hospital management
Estimated life expectancy <12 months
Pregnancy or breastfeeding
Trial design
Treatments tested in this trial
- Telemedicine-based follow-up
- Standard follow-up
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov