An interventional study of Telemedicine-based follow-up and Standard follow-up in Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Azienda Unita Sanitaria Locale di Piacenza. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Azienda Unita Sanitaria Locale di Piacenza · Not applicable, Interventional, and Treatment
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.
Heart failure with reduced ejection fraction (HFrEF) remains a major cause of morbidity, mortality, and healthcare utilization worldwide. Despite strong guideline recommendations supporting the early and comprehensive initiation of guideline-directed medical therapy (GDMT), real-world implementation remains suboptimal. Many patients are discharged on incomplete therapy and experience significant delays in treatment optimization, particularly during the early post-discharge phase, which is known to be a high-risk period for clinical instability. Recent evidence has highlighted the importance of rapid and structured GDMT optimization, with early intensification strategies associated with improved clinical outcomes. However, traditional care pathways, largely based on in-person follow-up visits, are often limited by logistical constraints, reduced access, and delayed clinical reassessment. In this context, telemedicine has emerged as a promising tool to facilitate early follow-up, enhance monitoring, and support timely treatment adjustments.
The TELEHEART study is a prospective, randomized, controlled trial designed to evaluate whether a telemedicine-guided strategy can improve GDMT optimization compared with standard care in patients with newly diagnosed HFrEF following hospitalization for acute heart failure or recent clinical instability. Participants will be randomized to either a telemedicine-based follow-up strategy or standard in-person care. In the intervention arm, patients will undergo an early structured telemedicine consultation shortly after discharge, supported by remote monitoring of clinical parameters, including blood pressure, heart rate, oxygen saturation, body weight, and single-lead electrocardiogram recordings. This approach is intended to enable early reassessment and facilitate timely up-titration of GDMT in accordance with current guidelines. In the control arm, patients will receive standard follow-up according to local clinical practice. The primary objective of the study is to assess the effectiveness of the telemedicine-based strategy in improving GDMT optimization, measured through a predefined GDMT score reflecting both the initiation and up-titration of the four foundational drug classes for HFrEF, according to a structured and standardized scoring system (detailed in the Outcome Measures section).
A key secondary objective is to evaluate the safety of replacing the first post-discharge in-person clinical evaluation with a structured telemedicine consultation. Safety will be assessed using a predefined composite endpoint including worsening renal function (defined as a ≥30% reduction in eGFR or eGFR \<30 mL/min/1.73m²), significant hyperkalemia (serum potassium >5.5 mEq/L), and symptomatic hypotension (systolic blood pressure \<90 mmHg associated with symptoms). Additional secondary objectives include the assessment of clinical outcomes, such as hospital readmissions and emergency department visits, as well as patient-reported outcomes. Treatment adherence, quality of life, and patient satisfaction with the telemedicine approach will be evaluated using validated questionnaires, including the Morisky Medication Adherence Scale (MMAS-8), the Kansas City Cardiomyopathy Questionnaire (KCCQ), and the Telehealth Usability Questionnaire (TUQ). By integrating structured telemedicine into early post-discharge management, this study aims to determine whether a more proactive, remotely supported care model can safely enhance treatment optimization and improve patient-centered outcomes in HFrEF.
Inclusion criteria: Participants must meet all of the following criteria:
Exclusion Criteria:
Patients randomized to this arm will undergo an early structured telemedicine consultation after hospital discharge, supported by remote monitoring of clinical parameters including blood pressure, heart rate, oxygen saturation, body weight, and single-lead electrocardiogram. Follow-up is designed to enable early reassessment and facilitate timely initiation and up-titration of guideline-directed medical therapy (GDMT) according to current recommendations.
Other: Telemedicine-based follow-up
Patients randomized to this arm will receive standard post-discharge management according to local clinical practice, including in-person follow-up visits and GDMT optimization at the discretion of the treating physician.
Other: Standard follow-up
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.
Also known as: TELEHEART intervention
Usual care consisting of standard in-person clinical follow-up visits and treatment optimization according to routine clinical practice.
Change in guideline-directed medical therapy (GDMT) score
Change in GDMT score from baseline (at enrollment) to 6 months. The GDMT score (range 0-5) reflects prescription and dose optimization of guideline-directed medical therapy for heart failure (ACEi/ARB/ARNI, beta-blockers, MRAs, SGLT2 inhibitors), based on an adapted ADMINISTER score. ΔGDMT is defined as the difference between 6-month and baseline values. Full scoring details are provided in the study protocol.
Time frame: Baseline to 6 months
Incidence of therapy-related adverse events during GDMT optimization (worsening renal function, hyperkalemia, or symptomatic hypotension)
First occurrence of any of the following within 3 months after enrollment: 1. worsening renal function (≥30% decrease in eGFR from baseline or eGFR \<30 mL/min/1.73 m²); 2. hyperkalemia (serum potassium \>5.5 mEq/L); 3. symptomatic hypotension (systolic blood pressure \<90 mmHg with symptoms such as dizziness, presyncope, or syncope).
Time frame: 3 months
Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 6 months. The KCCQ score ranges from 0 to 100, with higher scores indicating better health status. An increase of ≥5 points is considered clinically meaningful.
Time frame: Baseline and 6 months
Patient satisfaction and usability assessed by the Telehealth Usability Questionnaire (TUQ)
Patient-reported satisfaction and usability of telemedicine follow-up assessed using the Telehealth Usability Questionnaire (TUQ). The TUQ score ranges from 1 to 7, with higher scores indicating better usability and satisfaction.
Time frame: Baseline and 6 months
Heart failure-related clinical events
Urgent outpatient visits, emergency department visits, or hospitalizations for heart failure worsening within 6 months after enrollment.
Time frame: 6 months
Plan to share: Undecided
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Azienda Unita Sanitaria Locale di Piacenza