Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT07154758
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry BAsed Optimization Of Therapy in Heart Failure
Sponsor:
Region Stockholm
Organization:
Study Overview
Official Title:
Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBOOT-HFrEF
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: