MedTrace Logo

Registry BAsed Optimization Of Therapy in Heart Failure

NCT07154758 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-09-04

No results posted yet for this 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.

Conditions

Interventions

OTHER

Screening for need of HFrEF GDMT implementation through SwedeHF

Screening for need of HFrEF GDMT implementation through SwedeHF

Sponsors & Collaborators

  • Region Stockholm

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154758 on ClinicalTrials.gov