Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
Recruiting · NCT07518030 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Unita Sanitaria Locale di Piacenza
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Participants must meet all of the following criteria:
- 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 criteria
- 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
Where it is running
1 location listed.
- Clinical Research Office, AUSL Piacenza - Piacenza, Italy