NCT07154758 Registry BAsed Optimization Of Therapy in Heart Failure
| NCT ID | NCT07154758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Stockholm |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-05-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07154758 clinical trial?
This trial is open to participants of all sexes, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07154758 currently recruiting?
Yes, NCT07154758 is actively recruiting participants. Contact the research team at gianluigi.savarese@ki.se for enrollment information.
Where is the NCT07154758 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Hemse, Sweden, Jönköping, Sweden, Stockholm, Sweden and 2 additional locations.
Who is sponsoring the NCT07154758 clinical trial?
NCT07154758 is sponsored by Region Stockholm. The trial plans to enroll 1,000 participants.
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