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Registry BAsed Optimization Of Therapy in Heart Failure

RecruitingNAAges any - anyAllRegion Stockholm
NCT07154758 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
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What it tests

  • Screening for need of HFrEF GDMT implementation through SwedeHF
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Where

6 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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