RecruitingNot ApplicableNCT07154758

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


Sponsor

Region Stockholm

Enrollment

1,000 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is using a Swedish national heart failure registry to evaluate whether heart failure patients are receiving optimally dosed medications as recommended by treatment guidelines. Researchers will compare outcomes between patients who are on optimized therapy versus those who are not. **You may be eligible if...** - You are registered in the Swedish Heart Failure Registry (SwedeHF) after January 2023 - You have had heart failure for more than 6 months - You have heart failure with reduced ejection fraction (the heart is pumping weakly, with EF of 40% or below) - You are capable of giving informed consent (for the screened group) **You may NOT be eligible if...** - You are currently in the process of having your heart failure medications adjusted - Your doctor believes you are unlikely to understand or follow the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERScreening for need of HFrEF GDMT implementation through SwedeHF

Screening for need of HFrEF GDMT implementation through SwedeHF


Locations(6)

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Hemse vårdcentral

Hemse, Sweden

Länssjukhuset Ryhov

Jönköping, Sweden

Karolinska University Hospital

Stockholm, Sweden

St Görans hospital

Stockholm, Sweden

Södersjukhuset

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07154758


Related Trials