Registry BAsed Optimization Of Therapy in Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT07154758
• Lead Sponsor: Region Stockholm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (6)

Sahlgrenska Universitetssjukhuset; 🇸🇪 Gothenburg, Sweden

Hemse vårdcentral; 🇸🇪 Hemse, Sweden

Länssjukhuset Ryhov; 🇸🇪 Jönköping, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

St Görans hospital; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden