Registry BAsed Optimization Of Therapy in Heart Failure (REBOOT-HFrEF)

Region Stockholm

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Screening for need of HFrEF GDMT implementation through SwedeHF

Study type: Interventional

Funder types: Other

Identifiers

NCT07154758

2023-04364-01

Details and patient eligibility

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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

Screening through SwedeHF

Experimental group

Description:

HFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF

Treatment:

Other: Screening for need of HFrEF GDMT implementation through SwedeHF

Usual care

No Intervention group

Description:

HFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation