Actively Recruiting

Phase Not Applicable
All Genders
NCT07154758

Registry BAsed Optimization Of Therapy in Heart Failure

Led by Region Stockholm · Updated on 2025-09-04

1000

Participants Needed

6

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Registry BAsed Optimization Of Therapy in Heart Failure

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Registration in SwedeHF with an index date after January 1st 2023 for the screening arm or hospital access after January 1st 2023 for controls
  • Heart failure duration longer than 6 months
  • Heart failure with reduced ejection fraction defined as an ejection fraction of 40% or less
  • Ability to provide signed informed consent (screening arm only)
Not Eligible

You will not qualify if you...

  • Currently undergoing optimization of heart failure therapy
  • Investigator's judgment that participant is unlikely to understand or comply with study procedures

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Actively Recruiting

2

Hemse vårdcentral

Hemse, Sweden

Actively Recruiting

3

Länssjukhuset Ryhov

Jönköping, Sweden

Actively Recruiting

4

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

5

St Görans hospital

Stockholm, Sweden

Actively Recruiting

6

Södersjukhuset

Stockholm, Sweden

Actively Recruiting

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Research Team

G

Gianluigi Savarese, MD PhD

CONTACT

C

Camilla Hage, RN, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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