Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
TELEHEART Trial: Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
Azienda Unita Sanitaria Locale di Piacenza
90 participants
Mar 20, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
- Availability of adequate digital literacy, either by the patient or a caregiver, defined as the ability to use electronic devices for remote communication (phone/video calls), transmission of vital parameters (body weight, blood pressure, heart rate), and interaction with digital health tools. In cases of insufficient patient digital skills, the presence of a caregiver with adequate digital competence is acceptable.
- Any etiology of HF is eligible, including ischemic, valvular, primary or infiltrative cardiomyopathies, iatrogenic or toxic causes, and tachycardia-induced cardiomyopathy.
Exclusion Criteria4
- 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
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Interventions
Structured telemedicine follow-up including early post-discharge consultation and remote multiparametric monitoring (blood pressure, heart rate, oxygen saturation, body weight, and single-lead electrocardiogram). Clinical data are reviewed by a dedicated healthcare team to enable early reassessment and timely optimization of guideline-directed medical therapy.
Usual care consisting of standard in-person clinical follow-up visits and treatment optimization according to routine clinical practice.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07518030