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Can remote monitoring ease heart failure care? new study aims to find out

NCT ID NCT07440472

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a remote monitoring model called RAPHAEL can work for people with heart failure who may need palliative care. About 90 adults will use a digital questionnaire for 4 weeks to report symptoms and needs, while their healthcare team reviews the results. The goal is to see if this approach is feasible and acceptable, not to test a new drug or device.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that remote monitoring of symptoms and palliative care needs is practical for heart failure patients, potentially improving care delivery.
What could go wrong
This is a small feasibility study with only 90 participants and no experimental treatment, so results may not apply broadly or lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with a confirmed diagnosis of heart failure receiving outpatient care at Hospital de Granollers who are identified as having worsening symptoms and/or palliative care needs and are eligible to participate in the RAPHAEL feasibility study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients 1. Adult patients (≥18 years) with the main diagnosis of HF according to current guidelines (20), living at home; recruitment will be stratified by sex and limited to 60-70% for either sex. 2. Screen positive for one of the three clinical "sensitizing" questions, intended to identify potential palliative care (PC) needs: 'Would I be surprised if this patient were to die within one year?' * A "No" response indicates possible palliative care needs. 'Has this patient experienced 'escalating care events' at least twice in the past year, including i) unscheduled hospitalizations for HF, ii) emergency department visits for HF, iii) visits to out-of-hours primary care services for HF, and/or iv) other similar escalating care events?' * A "Yes" response indicates possible PC needs. 'Is this patient experiencing persistent or worsening multidimensional symptoms (e.g., physical, psychological, social, or spiritual concerns) despite optimal HF treatment, such that a palliative assessment is indicated (upon discretion of the treating physician or nurse)?' * A "Yes" response indicates possible PC needs. 3. patient's or informal caregiver's ability to use technology (e.g., having internet access, owning a smartphone or tablet, or having someone available who can assist them). 4. capacity to provide informed consent. Primary Caregiver: 1. Informal caregiver who is present with the patient during the implementation of the intervention 2. ≥18 years 3. capacity to provide consent. Healthcare professionals: Two professionals identified by the consortium in each site, willing to be trained in the intervention to perform the feasibility study. Exclusion Criteria: 1. Acute events leading to multiple outpatient visits not related to the HF diagnosis. 2. severe cognitive impairment or language disorders as determined by the attending healthcare professional based on clinical judgment and medical record review. 3. simultaneous participation in another study. 4. inability to read and write in the language in which the study is conducted. Primary caregivers: 1. Cognitive impairment or language disorders determined by the attending healthcare professional. 2. inability to read and write in the language in which the study is conducted. Health care professionals: a) Inability to read and write fluently in the language(s) required for the study site and for using the digital questionnaire.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Switzerland

  • Linkopings Universitet

    Linköping, Sweden

  • Universitaetsklinikum Aachen

    Aachen, Germany

  • Universitat Internacional de Catalunya

    Barcelona, Spain

  • Universiteit Maastricht

    Maastricht, Netherlands

  • University College London

    London, United Kingdom

  • Università Degli Studi Di Brescia

    Brescia, Italy

  • Uniwersytet Medyczny Im Piastow Slaskich We Wroclawiu

    Wroclaw, Poland

  • Vilniaus Universitetas

    Vilnius, Lithuania

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