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Can a wearable device keep heart failure patients out of the hospital?

NCT ID NCT07484009

Disease control Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new approach using a wearable device called ReDS to monitor fluid levels in adults hospitalized for heart failure. The goal is to see if this method reduces the risk of death, readmission, or urgent visits within a month after discharge. About 1,014 participants will be tracked, and the approach will be compared to standard 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,014 people

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

Started

Jan 2026

Expected to finish

Aug 2027

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.

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: 1. Hospitalized due to heart failure as the main reason, including the presence of symptoms and signs of congestion, regardless of the left ventricular ejection fraction (LVEF). 2. NT-proBNP greater than 1000 pg/L or BNP greater than 300 pg/L upon admission. Exclusion Criteria: 1. Height less than 150 cm or greater than 190 cm or body mass index (BMI) less than 22 or greater than 39, conditions where the use of ReDS is not approved. 2. Patients requiring inotropes (levosimendan is allowed) or vasopressors upon admission, with mechanical support, or heart transplant recipients. 3. Any malformation or variant affecting the right lung anatomy (e.g., a pacemaker). 4. Patients with any heart disease requiring a planned surgical intervention (CABG, valve disease, or other) or percutaneous (TAVR, STE-ACS, mitral or tricuspid valve repair, CRT) during the clinical trial. 5. Chronic kidney disease with a GFR \<20 or on hemodialysis. 6. Life expectancy less than 12 months due to non-cardiological origin. 7. Participation in another clinical trial with intervention.

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Conditions

The condition(s) this trial relates to.

Edema heart failure

As listed by the trial registrant

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

Acute heart failure (AHF) Heart failure (for example, fluid overload) Heart failure hospitalization

How to take part

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

  1. The places running it

    25 sites. 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

  • 12 de Octubre University Hospital

    RECRUITING

    Madrid, Spain

  • Arnau de Vilanova University Hospital

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Bellvitge University Hospital

    RECRUITING

    Barcelona, Spain

  • Clínico San Carlos University Hospital

    NOT_YET_RECRUITING

    Madrid, Spain

  • Clínico University Hospital

    NOT_YET_RECRUITING

    Valencia, Spain

  • Complejo Asistencial Universitario de Salamanca

    NOT_YET_RECRUITING

    Salamanca, Spain

  • Complejo Hospitalario Universitario de Santiago

    RECRUITING

    Santiago de Compostela, Spain

  • Dr Josep Trueta University Hospital

    RECRUITING

    Girona, Spain

  • Fundación Jiménez Díaz University Hospital

    NOT_YET_RECRUITING

    Madrid, Spain

  • Gregorio Marañón University Hospital

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Clinic

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Hospital General Universitario de Toledo

    NOT_YET_RECRUITING

    Toledo, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Spain

  • La Paz University Hospital

    RECRUITING

    Madrid, Spain

  • La Princesa University Hospital

    NOT_YET_RECRUITING

    Madrid, Spain

  • Marqués de Valdecilla University Hospital

    NOT_YET_RECRUITING

    Santander, Spain

  • Puerta de Hierro Majadahonda University Hospital

    RECRUITING

    Madrid, Spain

  • Ramón y Cajal University Hospital

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Reina Sofía University Hospital

    RECRUITING

    Córdoba, Spain

  • San Juan Despí Moisès Broggi Hospital

    RECRUITING

    Sant Joan Despí, Spain

  • Sant Joan XXIII University Hospital

    NOT_YET_RECRUITING

    Tarragona, Spain

  • Vall d'Hebrón University Hospital

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Virgen de la Arrixaca

    NOT_YET_RECRUITING

    Murcia, Spain

  • Virgen de la Macarena University Hospital

    NOT_YET_RECRUITING

    Seville, Spain

  • Virgen de la Victoria University Hospital

    RECRUITING

    Málaga, Spain

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