Registry BAsed Optimization Of Therapy in Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRegion Stockholm
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Under optimization of HF therapy
In judgment of the investigator unlikely to understand or comply with study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Screening for need of HFrEF GDMT implementation through SwedeHF
Other interventionScreening for need of HFrEF GDMT implementation through SwedeHF
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Screening through SwedeHFExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants experiencing at least one event of treatment optimization
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
Time frame
End of implementation for the screening arm; 1-year from index date for the control armSecondary outcomes
1
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.
Time frame
End of implementation for the screening arm; 1-year from index date for the control arm2
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.
Time frame
End of implementation for the screening arm; 1-year from index date for the control arm3
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.
Time frame
End of implementation for the screening arm; 1-year from index date for the control arm4
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.
Time frame
End of implementation for the screening arm; 1-year from index date for the control armOther outcomes
1
Number of participants referred for physiotherapy in the interventional vs. control arm.
Referral for physiotherapy (Yes/No) in the interventional vs. control arm.
Time frame
End of implementation for the screening arm; 1-year from index date for the control armSponsors and contacts
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Source ClinicalTrials.gov