Registry BAsed Optimization Of Therapy in Heart Failure
NCT ID: NCT07154758
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2024-05-01
2026-06-30
Brief Summary
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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)
Secondary outcome:
1. Number of participants experiencing at least one drug initiation in the interventional vs. control arm.
2. Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.
3. Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.
4. Number of participants screened for iron deficiency in the interventional vs. control arm.
Tertiary outcome:
1\. 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Screening through SwedeHF
HFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF
Screening for need of HFrEF GDMT implementation through SwedeHF
Screening for need of HFrEF GDMT implementation through SwedeHF
Usual care
HFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation
No interventions assigned to this group
Interventions
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Screening for need of HFrEF GDMT implementation through SwedeHF
Screening for need of HFrEF GDMT implementation through SwedeHF
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Responsible Party
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Gianluigi Savarese
MD, PhD
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Swedish Heart Failure Registry webpage
Other Identifiers
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2023-04364-01
Identifier Type: -
Identifier Source: org_study_id
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