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NCT07154758Recruiting

Registry BAsed Optimization Of Therapy in Heart Failure

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

Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
15 Aug 2025
Start date
1 May 2024
Primary completion date
30 Jun 2026
Lead sponsor
Region Stockholm
NCT number
NCT07154758

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 1 May 2024 to the primary completion date, 30 Jun 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Under optimization of HF therapy

Age

  • 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)

Who the study is looking for

  • 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)

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sahlgrenska Universitetssjukhuset
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GothenburgSwedenRecruiting
Hemse Vårdcentral
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HemseSwedenRecruiting
Lanssjukhuset Ryhov
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JönköpingSwedenRecruiting
St Görans hospital
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StockholmSwedenRecruiting
Karolinska University Hospital
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StockholmSwedenRecruiting
Södersjukhuset
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StockholmSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.