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TRANSFORM Heart Failure with Reduced Ejection Fraction

NCT04872959 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

  • Heart Failure, Systolic

Interventions

OTHER

HealthReveal

In the Intervention arm, for each study visit, the site will receive a pre-visit assessment of GDMT accompanied by recommended adjustment(s) using information extracted weekly from the sites' EHR. The recommended adjustment(s) will be conveyed using proprietary software from HealthReveal, with a suggested follow up plan. All reminders regarding dosing targets are based on the 2020 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment. Additionally, during visits at baseline, 3 months, and 6 months, the KCCQ-23 will be completed. In the Usual Care arm, during visits at baseline, 3 months, and 6 months, the KCCQ-23 will be completed.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2023-01-01
Completion
2024-05-31

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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 NCT04872959 on ClinicalTrials.gov