Using the Swedish Heart Failure Registry to improve treatment for reduced ejection fraction

Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic

This project will test whether screening people with HFrEF in the Swedish Heart Failure Registry can increase starts or dose‑ups of guideline heart‑failure medicines, iron testing, and referrals for devices or physiotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Sex: All
• Sponsor: Region Stockholm (Government)
• Locations: 6 sites (Gothenburg and 5 other locations)
• Trial ID: NCT07154758 on ClinicalTrials.gov

What this trial studies

The project uses the SwedeHF registry to screen patients with heart failure and reduced ejection fraction (EF ≤40%) for gaps in guideline‑directed medical therapy, iron deficiency screening/treatment, device indications (CRT/ICD), and physiotherapy referral. Identified patients in the screening arm are flagged for implementation actions and compared with a sex‑ and age‑matched control group at participating centers. The primary outcome is a composite of at least one drug initiation or uptitration (SGLT2i, MRA, BB, RASi/ARNi, iv iron), iron deficiency screening, or referral for device therapy. Eligible participants have HFrEF for more than six months and are registered in SwedeHF or have hospital access after January 1, 2023, with informed consent required for the screening arm.

Who should consider this trial

Good fit: Ideal candidates are adults with heart failure with reduced ejection fraction (EF ≤40%), HF duration >6 months, registered in SwedeHF (or with hospital access after Jan 1, 2023), and able to give informed consent for the screening arm.

Not a fit: Patients already optimized on guideline‑directed therapy, those not recorded in the Swedish registry, unable to consent, or judged unlikely to comply with procedures may not gain benefit from the intervention.

Why it matters

Potential benefit: If successful, more people with HFrEF could receive recommended medications, iron treatment, and device referrals, which may lower hospitalizations and improve clinical outcomes.

How similar studies have performed: Registry‑based quality improvement and implementation programs in cardiovascular care have previously increased uptake of guideline therapies, but randomized data specifically using SwedeHF for this multifaceted approach are limited.

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)

Where this trial is running

Gothenburg and 5 other locations

• Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (Recruiting)
• Hemse vårdcentral — Hemse, Sweden (Recruiting)
• Länssjukhuset Ryhov — Jönköping, Sweden (Recruiting)
• Karolinska University Hospital — Stockholm, Sweden (Recruiting)
• St Görans hospital — Stockholm, Sweden (Recruiting)
• Södersjukhuset — Stockholm, Sweden (Recruiting)

Study contacts

• Study coordinator: Gianluigi Savarese, MD PhD

Conditions Heart Failure; Implementation; Guideline-directed medical therapy; registry; Swedish Heart Failure Registry