Heart Failure, SystolicTRANSFORMHFrEFNCT04872959
TRANSFORM Heart Failure with Reduced Ejection Fraction
A study testing HealthReveal in people with Heart Failure, Systolic, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- HealthReveal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2021to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Heart Failure, Systolic
- Being tested
- HealthReveal
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthRevealOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | No intervention | Will not use HealthReveal to titrate the doses of Entresto/ other treatments for HFrEF. |
| Interventional- Health Reveal | Experimental | 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. Receives: Other: HealthReveal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 6 months
Secondary outcomes (2)
Relative change in actual achieved doses of individual classes of pivotal therapies (RASi/beta blocker/ MRA/SGLT2i).
- Relative change in actual achieved doses of individual classes of pivotal therapies (RASi/beta blocker/ MRA/SGLT2i).
Measured: baseline to 6 months
change in achievement of target doses
- Relative change in achievement of target doses (yes/no) of pivotal therapies (RASi/beta blocker/MRA/SGLT2i).
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start22 Oct 2021
- Primary completion1 Jan 2023
- Study completionMay 2024 (estimated)
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Cardiology
- Responsible party
- Principal investigator, James L. Januzzi, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872959
- Sponsor's protocol ID
- Pro00047392
- Acronym
- TRANSFORMHFrEF
- Status last verified
- Nov 2024
- First submitted
- 26 Apr 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: results
Publications
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.
PubMed 28625374Greene 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.
PubMed 30025570Ibrahim 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.
PubMed 29752128Yancy 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.
PubMed 29277252
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSFORM Heart Failure with Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT04872959
- Acronym / sponsor ID
- TRANSFORMHFrEF / Pro00047392
- Conditions
- Heart Failure, Systolic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American College of Cardiology
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | No intervention | –Will not use HealthReveal to titrate the doses of Entresto/ other treatments for HFrEF. |
| Interventional- Health Reveal | Experimental | Other: HealthRevealThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthRevealIn 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. | Other | Interventional- Health Reveal |
Primary outcome
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.
Time frame: baseline to 6 months
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.
2 secondary outcomes
Relative change in actual achieved doses of individual classes of pivotal therapies (RASi/beta blocker/ MRA/SGLT2i).
Time frame: baseline to 6 months
change in achievement of target doses
Time frame: baseline to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 28625374DeVore 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.
- Background: PubMed 30025570Greene 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.
- Background: PubMed 29752128Ibrahim 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.
- Background: PubMed 29277252Yancy 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.
- Individual participant dataSharing planned: Undecided. results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HealthReveal in people with Heart Failure, Systolic, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872959, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.