NCT07518030 Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
| NCT ID | NCT07518030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Unita Sanitaria Locale di Piacenza |
| Condition | Heart Failure With Reduced Ejection Fraction (HFrEF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-03-20 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07518030 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction (HFrEF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07518030 currently recruiting?
Yes, NCT07518030 is actively recruiting participants. Contact the research team at ricerca@ausl.pc.it for enrollment information.
Where is the NCT07518030 trial being conducted?
This trial is being conducted at Piacenza, Italy.
Who is sponsoring the NCT07518030 clinical trial?
NCT07518030 is sponsored by Azienda Unita Sanitaria Locale di Piacenza. The trial plans to enroll 80 participants.
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