Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure

Official title

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

Overview

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.

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.

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.

Primary outcome measures

• Change in guideline-directed medical therapy (GDMT) score [Time frame: Baseline to 6 months]

Secondary outcome measures (4)

• Incidence of therapy-related adverse events during GDMT optimization (worsening renal function, hyperkalemia, or symptomatic hypotension) [Time frame: 3 months]
• Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: Baseline and 6 months]
• Patient satisfaction and usability assessed by the Telehealth Usability Questionnaire (TUQ) [Time frame: Baseline and 6 months]
• Heart failure-related clinical events [Time frame: 6 months]

Eligibility criteria

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

• 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.
• 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.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Clinical Research Office, AUSL Piacenza — Piacenza

Publications

• Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients wi PMID 30153985
• Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31. PMID 39217271
• Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 PMID 36356631

Identifiers

NCT: NCT07518030 · TeleHeart · Unique protocol ID

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗