Image

Registry BAsed Optimization Of Therapy in Heart Failure

Registry BAsed Optimization Of Therapy in Heart Failure

Recruiting
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

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 details
    Heart Failure

NCT07154758

Region Stockholm

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.