Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Secondary outcome:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening through SwedeHF | Experimental | HFrEF 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening for need of HFrEF GDMT implementation through SwedeHF | Other | Screening for need of HFrEF GDMT implementation through SwedeHF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing at least one event of treatment optimization | Number of participants experiencing at least one of the following:
| End of implementation for the screening arm; 1-year from index date for the control arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of implementation for the screening arm; 1-year from index date for the control arm |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants referred for physiotherapy in the interventional vs. control arm. | Referral for physiotherapy (Yes/No) in the interventional vs. control arm. | End of implementation for the screening arm; 1-year from index date for the control arm |
Inclusion Criteria:
Exclusion Criteria:
Control population is sex and age matched with the SwedeHF screening arm (1:1)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianluigi Savarese, MD PhD | Contact | +46 8-524 870 75 | gianluigi.savarese@ki.se | |
| Camilla Hage, RN, PhD | Contact | +46 8-517 792 82 | camilla.hage@regionstockholm.se |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Universitetssjukhuset | Recruiting | Gothenburg | Sweden |
Not provided
| Label | URL |
|---|---|
| Swedish Heart Failure Registry webpage | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. | 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. | End of implementation for the screening arm; 1-year from index date for the control arm |
| Hemse vårdcentral | Recruiting | Hemse | Sweden |
|
| Länssjukhuset Ryhov | Recruiting | Jönköping | Sweden |
|
| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
|
| St Görans hospital | Recruiting | Stockholm | Sweden |
|
| Södersjukhuset | Recruiting | Stockholm | Sweden |
|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |