Registry BAsed Optimization Of Therapy in Heart Failure
REBOOT-HFrEF
Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic
1 other identifier
interventional
1,000
1 country
6
Brief Summary
Rationale. Although several pharmacological treatments, namely renin-angiotensin-system inhibitors, sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists and sodium-glucose cotransporter-2 inhibitors, improve mortality/morbidity in heart failure with reduced ejection fraction (HFrEF), their use in clinical practice is still limited. Aim. The aim of this project is to use the Swedish HF registry to identify HFrEF patients in need of 1) treatment implementation (initiation of treatments/uptitration), 2) screening and treatment of ID, and 3) with an indication for HF devices (CRT or ICD) but not implanted device, 4) referral for physiotherapy. Outcomes. Primary outcome: number of participants experiencing at least one of the following:
- 1.Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)
- 2.ID screening
- 3.Referral for device therapy (CRT/ICD)
- 4.Number of participants experiencing at least one drug initiation in the interventional vs. control arm.
- 5.Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.
- 6.Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.
- 7.Number of participants screened for iron deficiency in the interventional vs. control arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started May 2024
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 15, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
September 4, 2025
August 1, 2025
2.2 years
August 15, 2025
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants experiencing at least one event of treatment optimization
Number of participants experiencing at least one of the following: 1. Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron) 2. ID screening 3. Initiation/planning for device CRT/ICD Outcome measured as variable yes/no
End of implementation for the screening arm; 1-year from index date for the control arm
Secondary Outcomes (4)
Number of participants experiencing at least one drug initiation in the interventional vs. control arm.
End of implementation for the screening arm; 1-year from index date for the control arm
Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.
End of implementation for the screening arm; 1-year from index date for the control arm
Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.
End of implementation for the screening arm; 1-year from index date for the control arm
Number of participants screened for iron deficiency in the interventional vs. control arm.
End of implementation for the screening arm; 1-year from index date for the control arm
Other Outcomes (1)
Number of participants referred for physiotherapy in the interventional vs. control arm.
End of implementation for the screening arm; 1-year from index date for the control arm
Study Arms (2)
Screening through SwedeHF
EXPERIMENTALHFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF
Usual care
NO INTERVENTIONHFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation
Interventions
Screening for need of HFrEF GDMT implementation through SwedeHF
Eligibility Criteria
You may qualify if:
- Registration in SwedeHF with an index date after January 1st 2023 for the screening arm. For controls, hospital access after January 1st 2023.
- HF duration \>6 months to ensure that patients had time to go through the treatment optimization process as recommended by the guidelines.
- HF with reduced EF (HFrEF) defined as categorical or continuous EF ≤40%
- Capable of giving signed informed consent (for the screening arm)
You may not qualify if:
- Under optimization of HF therapy
- In judgment of the investigator unlikely to understand or comply with study procedures
- Control population is sex and age matched with the SwedeHF screening arm (1:1)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Stockholmlead
Study Sites (6)
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Hemse vårdcentral
Hemse, Sweden
Länssjukhuset Ryhov
Jönköping, Sweden
Karolinska University Hospital
Stockholm, Sweden
St Görans hospital
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 15, 2025
First Posted
September 4, 2025
Study Start
May 1, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share