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TRANSFORM Heart Failure With Reduced Ejection Fraction (TRANSFORMHFrEF)

Primary Purpose

Heart Failure, Systolic

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HealthReveal
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Clinical diagnosis of HF with EF ≤40% documented within 1 year of enrollment
  • Receiving ≥1 oral medication for HF at study enrollment (including diuretics, ACEI/ARB/ARNI, beta-blockers, MRA, SGLT2i or thiazide diuretics.

Exclusion Criteria:

  • Current or anticipated participation in a clinical trial
  • Currently receiving comfort care or enrolled in hospice
  • Life expectancy <1 year
  • History of or plan for heart transplantation or left ventricular assist device
  • Current or planned hemodialysis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual Care Arm

    Interventional- Health Reveal

    Arm Description

    Will not use HealthReveal to titrate the doses of Entresto/ other treatments for HFrEF.

    The interventional arm will be provided tools to augment quality of care and build the patient and physician relationship through trust and shared goal-setting. Prior to each patient appointment, on a customized GDMT Dashboard, the site will receive a pre-visit assessment of GDMT accompanied by recommended adjustment(s) using information extracted weekly from the sites' electronic health record (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, patient-reported outcomes/QOL will be assessed.

    Outcomes

    Primary Outcome Measures

    average composite endpoint of target dose achievement for the main classes of drugs (RASi/beta blockers/MRA/SGLT2i) among eligible patients without documented contraindications or intolerance.
    From baseline to 6 months change in average composite endpoint of target dose achievement for the main classes of drugs (RASi/beta blockers/MRA/SGLT2i) among eligible patients without documented contraindications or intolerance. Goal doses will be based on the 2020 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment (4). Numerator = receiving ARNI/ACEI/ARB at 50% or higher of target dose + receiving evidence-based beta blocker at 50% or higher of target dose + receiving MRA at 50% or higher of target dose + receiving SGLT2i at 50% or higher of target dose. Denominator = eligible to receive ARNI/ACEI/ARB and no documented reason for not receiving higher dose, eligible to receive evidence-based beta blocker and no documented reason for not receiving higher dose.

    Secondary Outcome Measures

    Relative change in actual achieved doses of individual classes of pivotal therapies (RASi/beta blocker/ MRA/SGLT2i).
    1) Relative change in actual achieved doses of individual classes of pivotal therapies (RASi/beta blocker/ MRA/SGLT2i).
    change in achievement of target doses
    2) Relative change in achievement of target doses (yes/no) of pivotal therapies (RASi/beta blocker/MRA/SGLT2i).

    Full Information

    First Posted
    April 26, 2021
    Last Updated
    March 13, 2023
    Sponsor
    Massachusetts General Hospital
    Collaborators
    American College of Cardiology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04872959
    Brief Title
    TRANSFORM Heart Failure With Reduced Ejection Fraction
    Acronym
    TRANSFORMHFrEF
    Official Title
    TRANSFORM Heart Failure With Reduced Ejection Fraction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    sponsor decision
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    American College of Cardiology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Systolic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care Arm
    Arm Type
    No Intervention
    Arm Description
    Will not use HealthReveal to titrate the doses of Entresto/ other treatments for HFrEF.
    Arm Title
    Interventional- Health Reveal
    Arm Type
    Experimental
    Arm Description
    The interventional arm will be provided tools to augment quality of care and build the patient and physician relationship through trust and shared goal-setting. Prior to each patient appointment, on a customized GDMT Dashboard, the site will receive a pre-visit assessment of GDMT accompanied by recommended adjustment(s) using information extracted weekly from the sites' electronic health record (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, patient-reported outcomes/QOL will be assessed.
    Intervention Type
    Other
    Intervention Name(s)
    HealthReveal
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    average composite endpoint of target dose achievement for the main classes of drugs (RASi/beta blockers/MRA/SGLT2i) among eligible patients without documented contraindications or intolerance.
    Description
    From baseline to 6 months change in average composite endpoint of target dose achievement for the main classes of drugs (RASi/beta blockers/MRA/SGLT2i) among eligible patients without documented contraindications or intolerance. Goal doses will be based on the 2020 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment (4). Numerator = receiving ARNI/ACEI/ARB at 50% or higher of target dose + receiving evidence-based beta blocker at 50% or higher of target dose + receiving MRA at 50% or higher of target dose + receiving SGLT2i at 50% or higher of target dose. Denominator = eligible to receive ARNI/ACEI/ARB and no documented reason for not receiving higher dose, eligible to receive evidence-based beta blocker and no documented reason for not receiving higher dose.
    Time Frame
    baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    Relative change in actual achieved doses of individual classes of pivotal therapies (RASi/beta blocker/ MRA/SGLT2i).
    Description
    1) Relative change in actual achieved doses of individual classes of pivotal therapies (RASi/beta blocker/ MRA/SGLT2i).
    Time Frame
    baseline to 6 months
    Title
    change in achievement of target doses
    Description
    2) Relative change in achievement of target doses (yes/no) of pivotal therapies (RASi/beta blocker/MRA/SGLT2i).
    Time Frame
    baseline to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years Clinical diagnosis of HF with EF ≤40% documented within 1 year of enrollment Receiving ≥1 oral medication for HF at study enrollment (including diuretics, ACEI/ARB/ARNI, beta-blockers, MRA, SGLT2i or thiazide diuretics. Exclusion Criteria: Current or anticipated participation in a clinical trial Currently receiving comfort care or enrolled in hospice Life expectancy <1 year History of or plan for heart transplantation or left ventricular assist device Current or planned hemodialysis

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    results
    Citations:
    PubMed Identifier
    28625374
    Citation
    DeVore AD, Thomas L, Albert NM, Butler J, Hernandez AF, Patterson JH, Spertus JA, Williams FB, Turner SJ, Chan WW, Duffy CI, McCague K, Mi X, Fonarow GC. Change the management of patients with heart failure: Rationale and design of the CHAMP-HF registry. Am Heart J. 2017 Jul;189:177-183. doi: 10.1016/j.ahj.2017.04.010. Epub 2017 Apr 29.
    Results Reference
    background
    PubMed Identifier
    30025570
    Citation
    Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351-366. doi: 10.1016/j.jacc.2018.04.070.
    Results Reference
    background
    PubMed Identifier
    29752128
    Citation
    Ibrahim NE, Song Y, Cannon CP, Doros G, Trebnick A, Russo P, Ponirakis A, Alexanian C, Januzzi JL Jr. Retraction notice to Addition or removal of guideline directed medical therapy in ambulatory patients with heart failure with reduced ejection fraction relative to change in symptom severity: An analysis from the PINNACLE (Practice Innovation and Clinical Excellence) Registry(R) [International Journal of Cardiology 254 (2018) 222-223]. Int J Cardiol. 2018 Mar 1;254:R1. doi: 10.1016/j.ijcard.2018.05.008. No abstract available.
    Results Reference
    background
    PubMed Identifier
    29277252
    Citation
    Yancy CW, Januzzi JL Jr, Allen LA, Butler J, Davis LL, Fonarow GC, Ibrahim NE, Jessup M, Lindenfeld J, Maddox TM, Masoudi FA, Motiwala SR, Patterson JH, Walsh MN, Wasserman A. 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2018 Jan 16;71(2):201-230. doi: 10.1016/j.jacc.2017.11.025. Epub 2017 Dec 22. No abstract available. Erratum In: J Am Coll Cardiol. 2018 Nov 13;72(20):2549.
    Results Reference
    background

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