Heart FailureHERMeSNCT03663907
Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial
A study testing Telemonitoring in people with Heart Failure, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The primary objective of the study is to evaluate the efficacy of a telemedicine-based follow-up strategy compared with usual care in the management of patients with chronic heart failure (HF) at high risk of clinical events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2018to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years old.
- Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning.
- Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria.
- Written informed consent must be obtained before any assessment is performed.
- Patients receiving oral standard medication for chronic heart failure (CHF).
- All patients will be eligible regardless the level of left ventricular ejection fraction (LVEF).
Who cannot join
- Age<18 years old.
- Participation in another clinical trial.
- Moderate or severe cognitive impairment without a competent caregiver.
- Lack of social support.
- Institutionalized patients.
- Life expectancy less than 1 year (excluding HF).
Show all 15Show fewer
- Candidates for home-based or institutional end-of-life care.
- Serious psychiatric illness.
- Planned cardiac surgery.
- Planned Heart transplantation or left ventricular assist device (LVAD) implant.
- Patients in hemodialysis program.
- Death before hospital discharge.
- The patient is unable or unwilling to give the informed consent to participate.
- The patient is considered not to be an adequate candidate for this study according to the decision of the local investigator.
- Unstable patients with signs of fluid overload or low cardiac output.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
The primary objective of the study is to evaluate the efficacy of a telemedicine-based follow-up strategy compared with usual care in the management of patients with chronic heart failure (HF) at high risk of clinical events.
Read the detailed description
The HERMeS Trial (Heart failure Events reduction with Remote Monitoring and eHealth Support) is a multicenter, prospective, randomized, open label, observational investigator initiated study to assess the effect on cardiovascular mortality and non-fatal heart failure (HF) events of a telemedicine-based comprehensive management program for patients with chronic HF by means of remote daily telemonitoring of signs and symptoms of HF and remote structured follow-up using videoconference. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.
In this study we aim to compare the strategy of providing nurse-based structured follow-up to high-risk chronic HF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nurse-based follow-up health care using videoconference (tele-intervention).
The main hypothesis of the study is that daily telemonitoring of clinical variables and symptoms in high-risk patients with HF allows early detection of decompensations by decreasing the number of fatal cardiovascular events or non-fatal HF events. As a secondary hypothesis we assume that tele-intervention using telemedicine may help to optimise neurohormonal treatment and deliver appropriate education to high-risk patients with HF; and delivery of care in high risk patients with HF through the combination of remote monitoring and tele-intervention may translate into a reduction of fatal and non fatal HF-related events.
- Conditions
- Heart Failure
- Being tested
- Telemonitoring
- Keywords
- Telemedicine, Telemonitoring, Disease Management, Chronic Care Model, Transitional Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringProcedure or surgery
The system (the home tele-healthcare platform) designed jointly by engineers and clinical personal to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring. The system allow weekly follow up through videoconferences.
Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses daily.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Structured follow-up in the basis of using telemedicine. Telemedicine will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference. Receives: Procedure: Telemonitoring |
| Usual Care | No intervention | Patients with usual care follow-up in a heart failure program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of cardiovascular death or non-fatal heart failure events.
Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission.
Measured: Six months after inclusion of the patient
Secondary outcomes (8)
Readmission (all-cause, HF and cardiovascular) rate and total number.
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Days in hospital (all-cause, HF and cardiovascular).
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Rate of emergency visits.
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Rate of non-fatal HF events.
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Mortality for any cause and cardiovascular mortality.
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Patient satisfaction using a Likert-type scale.
Comparison of both strategies at the end of follow-up.
Measured: Six months after inclusion of the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start15 May 2018
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Principal investigator, Josep Comín, Hospital Universitari de Bellvitge
- Investigators
- Josep Comín Colet, MD,PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663907
- Sponsor's protocol ID
- IDIBELL- 2017/PR190/17
- Acronym
- HERMeS
- Status last verified
- Oct 2022
- First submitted
- 28 Aug 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yun S, Comin-Colet J, Calero-Molina E, Hidalgo E, Jose-Bazan N, Cobo Marcos M, Soria T, Llacer P, Fernandez C, Garcia-Pinilla JM, Cruzado C, Gonzalez-Franco A, Garcia-Marina EM, Morales-Rull JL, Sole C, Garcia-Romero E, Nunez J, Civera J, Fernandez C, Faraudo M, Moliner P, Formiga F, de-Juan Baguda J, Zegri-Reiriz I, Verdu-Rotellar JM, Vela E, Monterde D, Piera-Jimenez J, Carot-Sans G, Enjuanes C; HERMeS trial investigators group. Evaluation of mobile health technology combining telemonitoring and teleintervention versus usual care in vulnerable-phase heart failure management (HERMeS): a multicentre, randomised controlled trial. Lancet Digit Health. 2025 May;7(5):100866. doi: 10.1016/j.landig.2025.02.006. Epub 2025 May 14.
PubMed 40374486
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial
- ClinicalTrials.gov ID
- NCT03663907
- Acronym / sponsor ID
- HERMeS / IDIBELL- 2017/PR190/17
- Conditions
- Heart Failure
- Keywords
- Telemedicine, Telemonitoring, Disease Management, Chronic Care Model, Transitional Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Study start
- 15 May 2018 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 10 Sep 2018 (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.
The primary objective of the study is to evaluate the efficacy of a telemedicine-based follow-up strategy compared with usual care in the management of patients with chronic heart failure (HF) at high risk of clinical events.
Detailed description
The HERMeS Trial (Heart failure Events reduction with Remote Monitoring and eHealth Support) is a multicenter, prospective, randomized, open label, observational investigator initiated study to assess the effect on cardiovascular mortality and non-fatal heart failure (HF) events of a telemedicine-based comprehensive management program for patients with chronic HF by means of remote daily telemonitoring of signs and symptoms of HF and remote structured follow-up using videoconference. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.
In this study we aim to compare the strategy of providing nurse-based structured follow-up to high-risk chronic HF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nurse-based follow-up health care using videoconference (tele-intervention).
The main hypothesis of the study is that daily telemonitoring of clinical variables and symptoms in high-risk patients with HF allows early detection of decompensations by decreasing the number of fatal cardiovascular events or non-fatal HF events. As a secondary hypothesis we assume that tele-intervention using telemedicine may help to optimise neurohormonal treatment and deliver appropriate education to high-risk patients with HF; and delivery of care in high risk patients with HF through the combination of remote monitoring and tele-intervention may translate into a reduction of fatal and non fatal HF-related events.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Procedure: TelemonitoringStructured follow-up in the basis of using telemedicine. Telemedicine will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference. |
| Usual Care | No intervention | –Patients with usual care follow-up in a heart failure program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old.
- Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning.
- Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria.
- Written informed consent must be obtained before any assessment is performed.
- Patients receiving oral standard medication for chronic heart failure (CHF).
Key exclusion criteria (15 listed)
- Age<18 years old.
- Participation in another clinical trial.
- Moderate or severe cognitive impairment without a competent caregiver.
- Lack of social support.
- Institutionalized patients.
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 |
|---|---|---|
| TelemonitoringThe system (the home tele-healthcare platform) designed jointly by engineers and clinical personal to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring. The system allow weekly follow up through videoconferences. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses daily. | Procedure or surgery | Telemonitoring |
Primary outcome
Occurrence of cardiovascular death or non-fatal heart failure events.
Time frame: Six months after inclusion of the patient
Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission.
8 secondary outcomes
Readmission (all-cause, HF and cardiovascular) rate and total number.
Time frame: Six months after inclusion of the patient.
Days in hospital (all-cause, HF and cardiovascular).
Time frame: Six months after inclusion of the patient.
Rate of emergency visits.
Time frame: Six months after inclusion of the patient.
Rate of non-fatal HF events.
Time frame: Six months after inclusion of the patient.
Mortality for any cause and cardiovascular mortality.
Time frame: Six months after inclusion of the patient.
Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
Time frame: Six months after inclusion of the patient.
Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
Time frame: Six months after inclusion of the patient.
Patient satisfaction using a Likert-type scale.
Time frame: Six months after inclusion of the patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 40374486Yun S, Comin-Colet J, Calero-Molina E, Hidalgo E, Jose-Bazan N, Cobo Marcos M, Soria T, Llacer P, Fernandez C, Garcia-Pinilla JM, Cruzado C, Gonzalez-Franco A, Garcia-Marina EM, Morales-Rull JL, Sole C, Garcia-Romero E, Nunez J, Civera J, Fernandez C, Faraudo M, Moliner P, Formiga F, de-Juan Baguda J, Zegri-Reiriz I, Verdu-Rotellar JM, Vela E, Monterde D, Piera-Jimenez J, Carot-Sans G, Enjuanes C; HERMeS trial investigators group. Evaluation of mobile health technology combining telemonitoring and teleintervention versus usual care in vulnerable-phase heart failure management (HERMeS): a multicentre, randomised controlled trial. Lancet Digit Health. 2025 May;7(5):100866. doi: 10.1016/j.landig.2025.02.006. Epub 2025 May 14.
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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. This study is not recruiting at the moment.
Josep Comín Colet, MD,PhD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Heart Failure, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 6 inclusion and 15 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: finished, as of the sponsor's last update on 26 Oct 2022. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of cardiovascular death or non-fatal heart failure events. (time frame: Six months after inclusion of the patient). 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 NCT03663907, which also lists 1 linked publication.
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 26 Oct 2022.