Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial

NCT03663907 | Completed

• 1 other identifier: IDIBELL- 2017/PR190/17
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

Telemedicine; Telemonitoring; Disease Management; Chronic Care Model; Transitional Care

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months after inclusion of the patient

Secondary Outcomes (8)

• Readmission (all-cause, HF and cardiovascular) rate and total number.

  Six months after inclusion of the patient.

• Days in hospital (all-cause, HF and cardiovascular).

  Six months after inclusion of the patient.

• Rate of emergency visits.

  Six months after inclusion of the patient.

• Rate of non-fatal HF events.

  Six months after inclusion of the patient.

• Mortality for any cause and cardiovascular mortality.

  Six months after inclusion of the patient.

Study Arms (2)

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.

Procedure: Telemonitoring

Usual Care

NO INTERVENTION

Patients with usual care follow-up in a heart failure program.

Interventions

Telemonitoring PROCEDURE

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.

Telemonitoring

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (1)

University Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• 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.

  PMID: 40374486 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Josep Comín Colet, MD,PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Community Heart Failure Unit, Cardiology Department. MD, PhD

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 10, 2018
• Study Start: May 15, 2018
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

ES (1)