NCT04334447

Implementing Standards of Care for Heart Failure Patients in General Practice - A Regional Disease Management Program

Status unknown Phase 4 Last updated 6 April 2020

What this trial tests

Phase 4 trial testing Improved primary care HF diagnostics in Heart Failure in 200 participants. Status unknown.

Timeline

4 November 2019

Primary endpoint
31 December 2021

31 July 2022

Quick facts

Lead sponsor	KU Leuven
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	200
Start date	4 November 2019
Primary completion	31 December 2021
Estimated completion	31 July 2022
Sites	1 location across Belgium

Drugs / interventions tested

• Improved primary care HF diagnostics
• Heart Failure education
• Structured transitional protocol planning post-discharge care

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

KU Leuven — full company profile →

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart failure (HF) is an important health problem. Most chronic HF management occurs in primary care. Although guidelines exist, there is an important implementation gap in current HF care in Belgium. We will conduct a non-randomized, non-controlled prospective observational trial to implement guideline-recommended best clinical practices in primary care in Leuven, a region of ± 100.000 inhabitants. These best clinical practices include education of general practitioners, access to natriuretic peptides and audits in the electronic health record (EHR), training and implementation of HF educators in primary care and a structured post-discharge transition process . The main objective is to implement best clinical practices in a dynamic way and study the implementation process. We will evaluate the implementation of several guideline-recommended best clinical practices to optimize the diagnosis and treatment of heart failure in a real-world primary care setting.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementing standards of care for heart failure patients in general practice - the IMPACT-B study protocol.
   Raat W, Smeets M, Van Pottelbergh G, Van Pottelbergh G, et al · · 2021 · cited 3× · PMID 33161831 · DOI 10.1080/00015385.2020.1844504
2. Implementing heart failure disease management in primary care: a mixed-methods analysis of the IMPACT-B study.
   Raat W, Smeets M, Van Pottelbergh G, Van de Putte M, et al · · 2025 · cited 2× · PMID 40685241 · DOI 10.1136/bmjopen-2024-093414