Heart Failure With Reduced Ejection Fraction (HFrEF)TELEHEARTNCT07518030
Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
A study testing Telemedicine-based follow-up and Standard follow-up in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- Telemedicine-based follow-up and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinical Research Office, AUSL Piacenza
Piacenza, 29121
Ufficio ricerca AUSL Piacenza, + 39 0523 302208, ricerca@ausl.pc.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Telemedicine-based follow-up, Standard follow-up
- Keywords
- Heart failure with reduced ejection fraction, Telemedicine, Guidelines direct medical therapy, Uptitration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-based follow-upOther
Also called TELEHEART intervention
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.
Standard follow-upOther
Usual care consisting of standard in-person clinical follow-up visits and treatment optimization according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (4)
Incidence of therapy-related adverse events during GDMT optimization (worsening renal function, hyperkalemia, or symptomatic hypotension)
First occurrence of any of the following within 3 months after enrollment:
- worsening renal function (≥30% decrease in eGFR from baseline or eGFR <30 mL/min/1.73 m²);
- hyperkalemia (serum potassium >5.5 mEq/L);
- symptomatic hypotension (systolic blood pressure <90 mmHg with symptoms such as dizziness, presyncope, or syncope).
Measured: 3 months
Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: Baseline and 6 months
Patient satisfaction and usability assessed by the Telehealth Usability Questionnaire (TUQ)
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.
Measured: Baseline and 6 months
Heart failure-related clinical events
Urgent outpatient visits, emergency department visits, or hospitalizations for heart failure worsening within 6 months after enrollment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Tedeschi, Azienda Unita Sanitaria Locale di Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518030
- Sponsor's protocol ID
- TeleHeart
- Other IDs
- Unique protocol ID
- Acronym
- TELEHEART
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 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.
PubMed 30153985Man 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.
PubMed 39217271Mebazaa 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.
PubMed 36356631
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELEHEART Trial: Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT07518030
- Acronym / sponsor ID
- TELEHEART / TeleHeart
- Keywords
- Heart failure with reduced ejection fraction, Telemedicine, Guidelines direct medical therapy, Uptitration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Telemedicine-guided management | Experimental | Other: Telemedicine-based follow-upPatients 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. |
| Standard of care | Active comparator | Other: Standard follow-upPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-based follow-upAlso: TELEHEART interventionStructured 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 | Telemedicine-guided management |
| Standard follow-upUsual care consisting of standard in-person clinical follow-up visits and treatment optimization according to routine clinical practice. | Other | Standard of care |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication: PubMed 30153985Koehler 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.
- Results publication: PubMed 39217271Man 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.
- Results publication: PubMed 36356631Mebazaa 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.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-based follow-up and Standard follow-up in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Office, AUSL Piacenza (+ 39 0523 302208, ricerca@ausl.pc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in guideline-directed medical therapy (GDMT) score (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07518030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.