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NCT Number: NCT07154758

Registry BAsed Optimization Of Therapy in Heart Failure

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska Universitetssjukhuset, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Screening for need of HFrEF GDMT implementation through SwedeHF

Other

Screening for need of HFrEF GDMT implementation through SwedeHF

Primary outcomes

  1. Number of participants experiencing at least one event of treatment optimization

    Time frame: 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:

    • Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron)
    • ID screening
    • Initiation/planning for device CRT/ICD Outcome measured as variable yes/no

Secondary outcomes

  1. Number of participants experiencing at least one drug initiation in the interventional vs. control arm.

    Time frame: 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.

  2. Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm.

    Time frame: 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.

  3. Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm.

    Time frame: 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.

  4. Number of participants screened for iron deficiency in the interventional vs. control arm.

    Time frame: 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.

Other outcomes

  1. Number of participants referred for physiotherapy in the interventional vs. control arm.

    Time frame: End of implementation for the screening arm; 1-year from index date for the control arm

    Referral for physiotherapy (Yes/No) in the interventional vs. control arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Hage, RN, PhD

CONTACT

[email protected]

‭+46 8-517 792 82‬

Gianluigi Savarese, MD PhD

CONTACT

[email protected]

‭+46 8-524 870 75‬

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study title

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

Acronym: REBOOT-HFrEF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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