Registry BAsed Optimization Of Therapy in Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening for need of HFrEF GDMT implementation through SwedeHF.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic
Overview
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
- Other Screening for need of HFrEF GDMT implementation through SwedeHF
Screening for need of HFrEF GDMT implementation through SwedeHF
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Sweden · 6 centers
- Sahlgrenska Universitetssjukhuset — Gothenburg
- Hemse vårdcentral — Hemse
- Länssjukhuset Ryhov — Jönköping
- Karolinska University Hospital — Stockholm
- St Görans hospital — Stockholm
- Södersjukhuset — Stockholm
Identifiers
NCT: NCT07154758 · 2023-04364-01