Study of Telemedicine-Guided Therapy Adjustment Versus Standard Care in Adults with Newly Diagnosed Heart Failure with Reduced Ejection Fraction
Led by Azienda Unita Sanitaria Locale di Piacenza · Updated on 2026-05-18
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a telemedicine-based follow-up strategy compared with standard in-person care for patients newly diagnosed with heart failure with reduced ejection fraction HFrEF. The study aims to see if telemedicine can improve the optimization of guideline-directed medical therapy GDMT over six months. This trial focuses on early treatment improvements during a high-risk period after hospital discharge, seeking to enhance clinical management and patient outcomes in real-world settings.
Participants will be randomly assigned to one of two groups. The telemedicine group will receive an early structured consultation after discharge supported by remote monitoring of vital signs such as blood pressure, heart rate, oxygen levels, body weight, and heart rhythm via single-lead electrocardiogram. This allows early reassessment and timely adjustment of heart failure medications. The comparison group will have standard care with in-person follow-ups and GDMT optimization as per usual clinical practice.
During the study, participants will undergo regular assessments of medication adherence, quality of life, and patient satisfaction using validated questionnaires. Researchers will monitor clinical events like hospital visits related to heart failure and assess safety through tracking kidney function, potassium levels, and blood pressure symptoms. The studys main outcome is the change in GDMT score from baseline to 6 months, reflecting medication initiation and dose increases. The total study duration and follow-up are designed to provide comprehensive data on the effectiveness and safety of telemedicine in managing HFrEF.
CONDITIONS
Brief Title
Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
Research Team
C
Clinical Research Office, AUSL Piacenza
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Recent diagnosis of heart failure with reduced ejection fraction (HFrEF) according to ESC criteria
No prior initiation of guideline-directed medical therapy (GDMT) for heart failure, or treatment limited to a single agent for other indications
Adequate digital literacy by patient or caregiver to use electronic devices for remote communication and monitoring
Any cause of heart failure is eligible, including ischemic, valvular, cardiomyopathies, iatrogenic, toxic, or tachycardia-induced
You will not qualify if you...
Ongoing treatment with two or more guideline-directed heart failure medications at diagnosis
Severe comorbidities or clinical instability requiring prolonged or continuous hospital management
Estimated life expectancy less than 12 months
Pregnancy or breastfeeding
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive either telemedicine-guided follow-up with remote monitoring and early therapy optimization or standard in-person follow-up according to routine clinical practice to optimize guideline-directed medical therapy for heart failure.
Early structured telemedicine consultation shortly after discharge and follow-up visits as per assigned care strategy
Follow-up
Duration - Up to 6 months after treatment start
Participants are monitored for safety and clinical outcomes including therapy-related adverse events, quality of life, patient satisfaction, and heart failure-related clinical events.
Assessments at baseline, 3 months, and 6 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Heart Failure With Reduced Ejection Fraction (HFrEF)
Actively Recruiting
1 location
Frequently Asked Questions
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Published Research Related To This Trial
Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial.