Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure

NCT07518030 | Recruiting

• 2 other identifiers: TeleHeartUnique protocol ID
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Keywords

Heart failure with reduced ejection fraction; Telemedicine; Guidelines direct medical therapy; Uptitration

Outcome Measures

Primary Outcomes (1)

• Change in guideline-directed medical therapy (GDMT) score

  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 Outcomes (4)

• Incidence of therapy-related adverse events during GDMT optimization (worsening renal function, hyperkalemia, or symptomatic hypotension)

  3 months

• Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Baseline and 6 months

• Patient satisfaction and usability assessed by the Telehealth Usability Questionnaire (TUQ)

  Baseline and 6 months

• Heart failure-related clinical events

  6 months

Study Arms (2)

Telemedicine-guided management

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

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

Interventions

Telemedicine-based follow-up OTHER

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.

Also known as: TELEHEART intervention

Telemedicine-guided management

Standard follow-up OTHER

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

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

Clinical Research Office, AUSL Piacenza

Piacenza, 29121, Italy

RECRUITING

Related Publications (3)

• 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 with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.

  PMID: 30153985 RESULT

• 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 RESULT

• 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 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.

  PMID: 36356631 RESULT

Central Study Contacts

Clinical Research Office, AUSL Piacenza

CONTACT

+ 39 0523 302208; ricerca@ausl.pc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention (telemedicine versus standard care), blinding of participants and investigators is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This is a prospective, randomized, controlled, parallel-group study comparing a telemedicine-guided follow-up strategy versus standard of care in patients with newly diagnosed HFrEF after recent hospitalization or clinical instability. Participants are randomized in a 1:1 ratio to either early structured telemedicine follow-up or standard in-person management, with the aim of improving GDMT optimization and evaluating safety outcomes

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IT (1)