Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872959
Status:
WITHDRAWN
Last Update Posted:
2023-03-15
First Post:
2021-04-26
Brief Title:
TRANSFORM Heart Failure With Reduced Ejection Fraction
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
TRANSFORM Heart Failure With Reduced Ejection Fraction
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSFORMHFrEF
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
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 12 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
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 12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None