Heart Failure
Conditions
Keywords
Implementation, Guideline-directed medical therapy, registry, Swedish Heart Failure Registry
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) 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.
Interventions
OTHERScreening for need of HFrEF GDMT implementation through SwedeHF
Screening for need of HFrEF GDMT implementation through SwedeHF
Sponsors
Region Stockholm
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants experiencing at least one event of treatment optimization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 initiation (SGLT2i, MRA, RASi or ARNi, BB, iv iron) in the interventional vs. 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 at least one drug dose up-titration (MRA, RASi or ARNi, BB) in the interventional vs. 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 patients referred for ICD/CRT in the interventional vs. 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 | Number of patients screened for ID in the interventional vs. control arm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Referral for physiotherapy (Yes/No) in the interventional vs. control arm. |
Countries
Sweden
Contacts
Primary ContactGianluigi Savarese, MD PhD
Backup ContactCamilla Hage, RN, PhD
Outcome results
None listed