Remote-guided medication up-titration for people with reduced ejection fraction heart failure
TELEHEART Trial: Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
This trial will see if telemedicine follow-up helps clinicians start and increase guideline-recommended heart failure medicines faster and more completely in adults with newly diagnosed HFrEF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Unita Sanitaria Locale di Piacenza Academic / other |
| Locations | 1 site (Piacenza, Italy) |
| Trial ID | NCT07518030 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, open-label trial comparing a telemedicine-based follow-up strategy with standard in-person ambulatory care for patients with newly diagnosed HFrEF. The telemedicine arm uses remote multiparametric monitoring and structured teleconsultations to guide medication up-titration, while the control arm follows conventional clinic visits. The primary outcome is change in a guideline-directed medical therapy (GDMT) score at 6 months; secondary outcomes include safety, treatment adherence, quality of life, and heart failure-related urgent visits, emergency department access, and hospitalizations. Eligible participants are adults not yet on full GDMT who have adequate digital literacy or caregiver support, and the trial is conducted at the Clinical Research Office, AUSL Piacenza (Piacenza, Italy).
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed HFrEF after hospitalization or recent clinical instability who are not yet on full GDMT and who have basic digital skills or an able caregiver.
Not a fit: Patients already on optimized GDMT, those without digital access or caregiver support, or those with advanced comorbidities that prevent safe medication uptitration are unlikely to benefit.
Why it matters
Potential benefit: If successful, telemedicine could speed and improve optimization of guideline-directed heart failure medications, potentially reducing symptoms and early hospital visits.
How similar studies have performed: Previous telemedicine trials in heart failure have shown benefits for follow-up, adherence, and sometimes reduced readmissions, but evidence specifically showing improved GDMT optimization is limited and still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: 1. Provision of written informed consent. 2. Age ≥18 years. 3. Recent diagnosis of HFrEF, defined according to ESC criteria, established in either an inpatient or outpatient setting. 4. 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. 5. 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. 6. 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 this trial is running
Piacenza, Italy
- Clinical Research Office, AUSL Piacenza — Piacenza, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Clinical Research Office, AUSL Piacenza
- Email: ricerca@ausl.pc.it
- Phone: + 39 0523 302208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.