Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure (TELEHEART)

May 15, 2026 updated by: Andrea Tedeschi, Azienda Unita Sanitaria Locale di Piacenza

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Research Office, AUSL Piacenza
  • Phone Number: + 39 0523 302208
  • Email: ricerca@ausl.pc.it

Study Locations

  • Italy
      • Piacenza, Italy, 29121
        • Recruiting
        • Clinical Research Office, AUSL Piacenza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria: Participants must meet all of the following criteria:

  1. Provision of written informed consent.
  2. Age ≥18 years.
  3. Recent diagnosis of HFrEF, defined according to ESC criteria, established in either an inpatient or outpatient setting.
  4. 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.
  5. Availability of adequate digital literacy, either by the patient or a caregiver, defined as the ability to use electronic devices for remote communication (phone/video calls), transmission of vital parameters (body weight, blood pressure, heart rate), and interaction with digital health tools. In cases of insufficient patient digital skills, the presence of a caregiver with adequate digital competence is acceptable.
  6. Any etiology of HF is eligible, including ischemic, valvular, primary or infiltrative cardiomyopathies, iatrogenic or toxic causes, and tachycardia-induced cardiomyopathy.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine-guided management
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
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 Names:
  • TELEHEART intervention
Active Comparator: Standard of care
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
Usual care consisting of standard in-person clinical follow-up visits and treatment optimization according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in guideline-directed medical therapy (GDMT) score
Time Frame: Baseline to 6 months
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.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure-related clinical events
Time Frame: 6 months
Urgent outpatient visits, emergency department visits, or hospitalizations for heart failure worsening within 6 months after enrollment.
6 months
Incidence of therapy-related adverse events during GDMT optimization (worsening renal function, hyperkalemia, or symptomatic hypotension)
Time Frame: 3 months

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).
3 months
Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Baseline and 6 months
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.
Baseline and 6 months
Patient satisfaction and usability assessed by the Telehealth Usability Questionnaire (TUQ)
Time Frame: Baseline and 6 months
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.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unita Sanitaria Locale di Piacenza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TeleHeart
  • Unique protocol ID (Other Identifier: AUSL Piacenza)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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