Heart FailureREBOOT-HFrEFNCT07154758
Registry BAsed Optimization Of Therapy in Heart Failure
A study testing Screening for need of HFrEF GDMT implementation through SwedeHF in people with Heart Failure, run by Region Stockholm at 6 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Screening for need of HFrEF GDMT implementation through SwedeHF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesSweden
- Study dates
- 1 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg
Charlotta Ljungman, MD, PhD, charlotta.ljungman@vgregion.se
- Recruiting
Hemse vårdcentral
Hemse
Ann Hoveland, MD, ann.hovland-tanneryd@gotland.se
- Recruiting
Länssjukhuset Ryhov
Jönköping
Patric Karlström, MD, PhD, patric.karlstrom@rjl.se
- Recruiting
Karolinska University Hospital
Stockholm
Camilla Hage, RN, PhD, camilla.hage@regionstockholm.se
- Recruiting
St Görans hospital
Stockholm
Ulrika Löfström, MD, ulrika.lofstrom@capiostgoran.se
- Recruiting
Södersjukhuset
Stockholm
Carin Corovic Cabrera, MD, PhD, carin.corovic-cabrera@regionstockholm.se
About this study
Official title: Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic
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.
Read more
Outcomes.
Primary outcome: number of participants experiencing at least one of the following:
- Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)
- ID screening
- Referral for device therapy (CRT/ICD)
Secondary outcome:
- Number of participants experiencing at least one drug initiation in the interventional vs. control arm.
- Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.
- Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.
- Number of participants screened for iron deficiency in the interventional vs. control arm.
Tertiary outcome:
- Number of participants referred for physiotherapy in the interventional vs. control arm.
Study design. 500 patients will be screened through the Swedish Heart Failure Registry and, whether not on optimal medical treatment, implementation will be started. Outcome will be compared with a control population of 500 patients not enrolled in SwedeHF.
- Conditions
- Heart Failure
- Being tested
- Screening for need of HFrEF GDMT implementation through SwedeHF
- Keywords
- Implementation, Guideline-directed medical therapy, registry, Swedish Heart Failure Registry
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for need of HFrEF GDMT implementation through SwedeHFOther
Screening for need of HFrEF GDMT implementation through SwedeHF
| Study group | Role | What they receive |
|---|---|---|
| Screening through SwedeHF | Experimental | HFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF Receives: Other: Screening for need of HFrEF GDMT implementation through SwedeHF |
| Usual care | No intervention | HFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing at least one event of treatment optimization
Number of participants experiencing at least one of the following:
- Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)
- ID screening
- Initiation/planning for device CRT/ICD Outcome measured as variable yes/no
Measured: 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.
Number of participants experiencing at least one drug initiation (SGLT2i, MRA, RASi or ARNi, BB, iv iron) in the interventional vs. control arm.
Measured: 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.
Number of participants experiencing at least one drug dose up-titration (MRA, RASi or ARNi, BB) in the interventional vs. control arm.
Measured: 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.
Number of patients referred for ICD/CRT in the interventional vs. control arm.
Measured: 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.
Number of patients screened for ID in the interventional vs. control arm.
Measured: End of implementation for the screening arm; 1-year from index date for the control arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gianluigi Savarese, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154758
- Sponsor's protocol ID
- 2023-04364-01
- Other IDs
- 2023
- Acronym
- REBOOT-HFrEF
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic
- ClinicalTrials.gov ID
- NCT07154758
- Acronym / sponsor ID
- REBOOT-HFrEF / 2023-04364-01
- Conditions
- Heart Failure
- Keywords
- Implementation, Guideline-directed medical therapy, registry, Swedish Heart Failure Registry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)
- ID screening
- Referral for device therapy (CRT/ICD)
Secondary outcome:
- Number of participants experiencing at least one drug initiation in the interventional vs. control arm.
- Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.
- Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.
- Number of participants screened for iron deficiency in the interventional vs. control arm.
Tertiary outcome:
- Number of participants referred for physiotherapy in the interventional vs. control arm.
Study design. 500 patients will be screened through the Swedish Heart Failure Registry and, whether not on optimal medical treatment, implementation will be started. Outcome will be compared with a control population of 500 patients not enrolled in SwedeHF.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening through SwedeHF | Experimental | Other: Screening for need of HFrEF GDMT implementation through SwedeHFHFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF |
| Usual care | No intervention | –HFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for need of HFrEF GDMT implementation through SwedeHFScreening for need of HFrEF GDMT implementation through SwedeHF | Other | Screening through SwedeHF |
Primary outcome
Number of participants experiencing at least one event of treatment optimization
Time frame: End of implementation for the screening arm; 1-year from index date for the control arm
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
4 secondary outcomes
Number of participants experiencing at least one drug initiation in the interventional vs. control arm.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of implementation for the screening arm; 1-year from index date for the control arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Swedish Heart Failure Registry webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for need of HFrEF GDMT implementation through SwedeHF in people with Heart Failure, run by Region Stockholm at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluigi Savarese, MD PhD (+46 8-524 870 75, gianluigi.savarese@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing at least one event of treatment optimization (time frame: End of implementation for the screening arm; 1-year from index date for the control arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.