Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Unita Sanitaria Locale di Piacenza
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Telemedicine-based follow-up
Other interventionStructured 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.
Standard follow-up
Other interventionUsual care consisting of standard in-person clinical follow-up visits and treatment optimization according to routine clinical practice.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Telemedicine-guided managementExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov