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RECRUITING
NCT07518030
NA

Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure

Sponsor: Azienda Unita Sanitaria Locale di Piacenza

View on ClinicalTrials.gov

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.

Official title: TELEHEART Trial: Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-03-20

Completion Date

2028-06-01

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

OTHER

Telemedicine-based 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.

OTHER

Standard follow-up

Usual care consisting of standard in-person clinical follow-up visits and treatment optimization according to routine clinical practice.

Locations (1)

Clinical Research Office, AUSL Piacenza

Piacenza, Italy