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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Hemse vårdcentral
RECRUITING
Hemse
Länssjukhuset Ryhov
RECRUITING
Jönköping
Karolinska University Hospital
RECRUITING
Stockholm
Södersjukhuset
RECRUITING
Stockholm
St Görans hospital
RECRUITING
Stockholm
Contact Information
Primary
Gianluigi Savarese, MD PhD
gianluigi.savarese@ki.se
‭+46 8-524 870 75‬
Backup
Camilla Hage, RN, PhD
camilla.hage@regionstockholm.se
‭+46 8-517 792 82‬
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 1000
Treatments
Experimental: Screening through SwedeHF
HFrEF patients enrolled in SwedeHF and screened for need of GDMT implementation through SwedeHF
No_intervention: Usual care
HFrEF patients not enrolled in the SwedeHF and therefore not undergoing screening for GDMT implementation
Related Therapeutic Areas
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov