NCT07518030Recruiting
Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
TELEHEART Trial: Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Apr 2026
- Start date
- Mar 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Diseases
- Heart failure
- NCT number
- NCT07518030
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Mar 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing treatment with two or more guideline-directed heart failure medications at the time of HFrEF diagnosis
Other
- Presence of severe comorbidities or clinical instability requiring prolonged or continuous hospital management
- Estimated life expectancy \<12 months
- Pregnancy or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Office, AUSL Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.