Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07518030

Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure

Led by Azienda Unita Sanitaria Locale di Piacenza · Updated on 2026-04-13

90

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent provided
  • Age 18 years or older
  • 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 one agent prescribed for another condition
  • Adequate digital literacy by patient or caregiver for remote communication and monitoring
  • Any cause of heart failure, including ischemic, valvular, cardiomyopathies, iatrogenic, toxic, or tachycardia-induced
Not Eligible

You will not qualify if you...

  • Ongoing treatment with two or more guideline-directed heart failure medications at HFrEF diagnosis
  • Severe comorbidities or clinical instability requiring prolonged hospital care
  • Estimated life expectancy less than 12 months
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinical Research Office, AUSL Piacenza

Piacenza, Italy, Italy, 29121

Actively Recruiting

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Research Team

C

Clinical Research Office, AUSL Piacenza

CONTACT

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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