Clinical Trial

Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure

Study acronym: TELEHEART
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 1 change
notable Enrollment reduced: 90 -> 80 participants 2026-05-19
Trial Details
NCT Number NCT07518030
Lead Sponsor Azienda Unita Sanitaria Locale di Piacenza
Conditions Heart Failure With Reduced Ejection Fraction (HFrEF)
Enrollment 80 participants
Start Date 2026-03-20
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-18