REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study
RELEASE-HF
1 other identifier
observational
6,480
1 country
34
Brief Summary
Telemedicine is gradually becoming accepted in heart failure (HF) management. Meta-analyses show a positive effect of telemedicine on hospital admission, length of stay, mortality, and costs. However, the magnitude of the effect is heterogeneous because of the variety in the HF population using telemedicine, components of telemedicine, and variety in considered costs. Despite the lack of clear guidance how to implement telemedicine within routine HF management, implementation of telemedicine is advocated by payers, private companies, and patient organizations. In this nationwide study the investigators aim to identify in which subgroup of HF patients telemedicine is (cost-)effective, and which intervention components of telemedicine are most (cost-)effective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 16, 2022
December 1, 2022
3 years
December 1, 2022
December 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days spent outside the hospital within one year of follow-up
The number of days will be derived from the number of hospital days and mortality status between follow-up moments.
12 months
Secondary Outcomes (6)
All-cause mortality
12 months
Change from baseline in functional status at 12 months
Baseline, 12 months
Change from baseline in health status at 12 months
Baseline, 12 months
Change from baseline in QoL (Quality of Life) at 12 months
Baseline, 12 months
Outpatient visits
12 months
- +1 more secondary outcomes
Study Arms (1)
Heart failure patients
According to the eligibility criteria specified below.
Interventions
Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management
Eligibility Criteria
Patients diagnosed with heart failure and who are treated at an outpatient clinic in the Netherlands, with or without telemedicine use.
You may qualify if:
- All heart failure patients newly admitted to a hospital outpatient clinic for HF
- All phenotypes of heart failure that meet the ESC 2021 guideline
- Patient who has been diagnosed with heart failure in a setting other than the one where the patient currently presents (primary, secondary or tertiary care)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (34)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
OLVG
Amsterdam, Netherlands
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, Netherlands
Wilhelmina Ziekenhuis Assen
Assen, Netherlands
Maasziekenhuis Pantein
Boxmeer, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Máxima MC
Eindhoven, Netherlands
Treant Zorggroep
Emmen, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Anna Ziekenhuis
Geldrop, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Ziekenhuisgroep Twente
Hengelo, Netherlands
Alrijne
Leiden, Netherlands
Maastricht UMC+
Maastricht, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Radoudumc
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Zuyderland Medisch Centrum
Sittard, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
Bernhoven
Uden, Netherlands
Diakonessenhuis
Utrecht, Netherlands
UMC Utrecht
Utrecht, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
Related Publications (1)
van Eijk J, Luijken K, Jaarsma T, Reitsma JB, Schuit E, Frederix GWJ, Derks L, Schaap J, Rutten FH, Brugts J, de Boer RA, Asselbergs FW, Trappenburg JCA; RELEASE-HF Investigators. RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands. BMJ Open. 2024 Jan 4;14(1):e078021. doi: 10.1136/bmjopen-2023-078021.
PMID: 38176879DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Folkert W. Asselbergs, MD, PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 1, 2022
First Posted
December 16, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
December 16, 2022
Record last verified: 2022-12