Screening for need of HFrEF GDMT implementation through SwedeHF
OtherScreening for need of HFrEF GDMT implementation through SwedeHF
NCT Number: NCT07154758
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.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Sahlgrenska Universitetssjukhuset, Gothenburg, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Control population is sex and age matched with the SwedeHF screening arm (1:1)
Screening for need of HFrEF GDMT implementation through SwedeHF
Time frame: 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:
Time frame: End of implementation for the screening arm; 1-year from index date for the control arm
Number of participants experiencing at least one drug initiation (SGLT2i, MRA, RASi or ARNi, BB, iv iron) in the interventional vs. control arm.
Time frame: End of implementation for the screening arm; 1-year from index date for the control arm
Number of participants experiencing at least one drug dose up-titration (MRA, RASi or ARNi, BB) in the interventional vs. control arm.
Time frame: End of implementation for the screening arm; 1-year from index date for the control arm
Number of patients referred for ICD/CRT in the interventional vs. control arm.
Time frame: End of implementation for the screening arm; 1-year from index date for the control arm
Number of patients screened for ID in the interventional vs. control arm.
Time frame: End of implementation for the screening arm; 1-year from index date for the control arm
Referral for physiotherapy (Yes/No) in the interventional vs. control arm.
Contact information is provided by the study sponsor or research team.
Camilla Hage, RN, PhD
CONTACT
+46 8-517 792 82
Gianluigi Savarese, MD PhD
CONTACT
+46 8-524 870 75
Region Stockholm
Other Gov
Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic
Acronym: REBOOT-HFrEF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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