Actively Recruiting
Registry BAsed Optimization Of Therapy in Heart Failure
Led by Region Stockholm · Updated on 2025-09-04
1000
Participants Needed
6
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Registry BAsed Optimization Of Therapy in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Registration in SwedeHF with an index date after January 1st 2023 for the screening arm or hospital access after January 1st 2023 for controls
- Heart failure duration longer than 6 months
- Heart failure with reduced ejection fraction defined as an ejection fraction of 40% or less
- Ability to provide signed informed consent (screening arm only)
You will not qualify if you...
- Currently undergoing optimization of heart failure therapy
- Investigator's judgment that participant is unlikely to understand or comply with study procedures
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Actively Recruiting
2
Hemse vårdcentral
Hemse, Sweden
Actively Recruiting
3
Länssjukhuset Ryhov
Jönköping, Sweden
Actively Recruiting
4
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
5
St Görans hospital
Stockholm, Sweden
Actively Recruiting
6
Södersjukhuset
Stockholm, Sweden
Actively Recruiting
Research Team
G
Gianluigi Savarese, MD PhD
CONTACT
C
Camilla Hage, RN, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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