Registry BAsed Optimization Of Therapy in Heart Failure

Condition(s) studied

Investigational drug(s) / intervention(s)

Screening for need of HFrEF GDMT implementation through SwedeHF: Screening for need of HFrEF GDMT implementation through SwedeHF

Study 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

Primary outcome measure(s)

• Number of participants experiencing at least one event of treatment optimization — End of implementation for the screening arm; 1-year from index date for the control arm
  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. Initiation/planning for device CRT/ICD Outcome measured as variable yes/no

Trial sites (6)

More Region Stockholm trials in Sweden

Other trials for the same condition