Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT04872959
Brief Summary:
The goal of the TRANSFORM-HFrEF trial will be to study the current guideline-directed medical therapy (GDMT) landscape for HFrEF and determine effective methods and models of increasing adherence to GDMT and improving Quality of Life (QOL) in outpatient settings within the context of the 20-minute visit. This will be achieved through a randomized evaluation that shifts standard clinical interview and documentation requirements outside the office visit and building the patient and physician relationship through trust and shared goal setting.
Specific Aims:
To evaluate the ability of ACC Solution Sets and Patient Resources to improve initiation and titration of GDMT for eligible patients with HFrEF Left Ventricle Ejection Fraction (LVEF) ≤ 40%.
To evaluate change in QOL between patients in the intervention arm and the Usual Care arm.
Examine the relative change in GDMT among higher risk versus lower-risk patients in the Intervention arm and Usual Care arm.
In this randomized registry trial, sites will be invited to participate in a 6-month study aimed at various processes of care in HFrEF. Sites would be informed that they might be asked to participate in an intensive intervention to improve GDMT prescription or in a study of QOL in HFrEF. Once a list of sites interested in participating is created, sites would be randomized into two arms: an intervention group and a usual care group.
Detailed Description:
Heart Failure (HF) is the cardiovascular epidemic of the 21st century, affecting millions of patients worldwide. It is believed that HF is the only cardiovascular diagnosis rising in incidence among elderly patients and is the #1 diagnosis leading to hospitalization among Medicare recipients. In addition to being increasingly prevalent, HF has a poor outlook after initial diagnosis and is associated with poor quality of life (QOL) in affected patients; this not only leads to the burden on patients, family, and other caregivers but also on the healthcare system. For all these reasons, optimizing the understanding and care of patients with HF is a major priority.
Although clinical practice guidelines clearly articulate optimal GDMT for the care of patients with HFrEF, implementation of GDMT into the management of such patients has proven to be suboptimal, with most patients under-treated relative to goal therapy.
To evaluate the contemporary status of GDMT delivery for HFrEF, the recent Change the Management of Patients with Heart Failure (CHAMP-HF) registry included 3518 patients from 150 primary care and cardiology practices (1,2). The mean age of this cohort was 66 ± 13 years, 29% were female, and mean EF was 29 ± 8%, thus representing a very characteristic population of patients with HFrEF.
Study:
NCT04872959
Study Brief:
Protocol Section:
NCT04872959