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Heart FailureREVeAL-HFNCT03845660

Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure

A study testing Electronic Alert in people with Heart Failure, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Heart failure is a complex and heterogenous disease with mortality and morbidity that equals more cancers. Numerous studies have examined the ability to improve prognostication from heart failure, ranging from basic statistical methodologies to machine learning, with impressive improvements in both predictive indices. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Electronic Alert
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,124 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 30 Dec 2021
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
  • NTproBNP levels of >500pg/mL within 24 hours of admission
  • Intravenous diuretics within 24 hours of admission

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: The REVeAL-HF Trial: Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure

Heart failure is a complex and heterogenous disease with mortality and morbidity that equals more cancers. Numerous studies have examined the ability to improve prognostication from heart failure, ranging from basic statistical methodologies to machine learning, with impressive improvements in both predictive indices. However, no study to date has examined, in a randomized fashion, the impact of providing prognostic information on provider behavior and downstream clinical outcomes. It is for this reason that the investigators plan to perform the Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure (REVeAL-HF) Trial within the Yale New Haven Health System. REVeAL-HF is a randomized, single-blind intervention trial that is testing the clinical impact of providing prognostic information to the provider on heart failure outcomes in the inpatient settings. The study hypothesis is that electronic alerting about prognostic information on heart failure patients along with links to guidelines will lead to reductions in all-cause mortality and 30-day HF hospitalizations via improved use of guideline directed medical therapy and more adequate decongestion.

Read the detailed description

Heart failure is the major cause of mortality and morbidity in the United States and Western Europe and prognosis in individual patients is highly variable. Quantifying a patient's survival prospects based on their overall risk profile has the potential to help identify those patients in need of more intensive monitoring and help target appropriate populations for therapies. In fact, several comprehensive risk scores in patients with heart failure are currently available for both reduced and preserved ejection fraction but their applicability to contemporary heart failure populations is unknown. Additionally, the impact of knowing a patient's prognostic information on treatment decisions in heart failure has never been studied. Therefore, guidelines do not recommend using risk assessments to decide on therapeutic decision making in heart failure due to a lack of data for this strategy. The investigators have proposed a randomized controlled trial be conducted of an electronic alert system that informs practitioners about their patients risk of inpatient mortality and 1-year predicted mortality using data from the electronic health record (EHR). The primary outcome for the trial will be a composite of all-cause mortality and 30-day risk of heart failure rehospitalization. The secondary outcomes will be length of stay, discharge doses of heart failure therapies, palliative care referral, referral for advanced therapies like transplant or mechanical circulatory support, referral to electrophysiology, and change in weight during hospitalization (aggressiveness of diuresis). The investigators will enroll into the trial across the hospitals that comprise the Yale New Haven Health System.

Conditions
Heart Failure
Being tested
Electronic Alert
Keywords
Heart Failure, Prognosis, Electronic Alerts
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic AlertBehavioural

    Patients randomized to the intervention will have an alert of their prognosis based on the best available prognostic models for inpatient and 1-year mortality generated with information from their electronic health record, which will consist of a "pop-up" when the provider accesses a patient record to enter a progress note after the definitions for inclusions into the study have been registered.

Study groups in NCT03845660
Study groupRoleWhat they receive
Usual CareNo interventionProviders taking care of patients randomized to this arm will have no alert related to the patients prognosis.
Electronic AlertExperimentalPatients randomized to the intervention will have an alert of their prognosis based on the best available prognostic models for inpatient and 1-year mortality generated with information from their electronic health record, which will consist of a "pop-up" when the provider accesses a patient record to enter a progress note after the definitions for inclusions into the study have been registered.
Receives: Behavioral: Electronic Alert

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-Cause Mortality

    All cause mortality will be monitored and reported.

    Measured: 1 Year

  2. Heart failure Re-hospitalization

    30-day risk of heart failure re-hospitalization will be assessed and reported.

    Measured: 30 Days Post Discharge

Secondary outcomes (6)

  1. Length of stay

    Average length of stay will be collected in Days

    Measured: 1 Year

  2. Discharge doses of heart failure therapies

    Discharge doses of guideline recommended heart failure therapies in milligrams (mg)

    Measured: 1 Year

  3. Palliative care referral

    Palliative care referrals will be collected and counted (Number)

    Measured: 1 Year

  4. Advanced therapies referral

    Referrals for advanced therapies like transplant or mechanical circulatory support will be collected and counted (number)

    Measured: 1 Year

  5. Electrophysiology referral

    Referrals to electrophysiology will be collected and counted (number)

    Measured: 1 Year

  6. Weight Change

    Weight change is defined as the change in weight during hospitalization (kg)

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2019
  2. Study start1 Jan 2020
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Sequential
Model description
Subjects will be recruited when electronically identified. The inclusion criteria will be all adults ≥18 years who have an NTproBNP levels of \>500 pg/mL and received intravenous diuretics within 24 hours of admission within the YNHS. Patients randomized to the intervention will have an alert of their prognosis based on the best available prognostic models for inpatient and 1-year mortality generated with information from their electronic health record, which will consist of a "pop-up" when providers accesses a patient record to enter a progress note.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
3,124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03845660
Sponsor's protocol ID
2000025000
Acronym
REVeAL-HF
Status last verified
Apr 2022
First submitted
11 Feb 2019
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be housed at Yale University.

Publications

  • Wilson FP, Greenberg JH. Acute Kidney Injury in Real Time: Prediction, Alerts, and Clinical Decision Support. Nephron. 2018;140(2):116-119. doi: 10.1159/000492064. Epub 2018 Aug 2.

    PubMed 30071528

  • Martin M, Wilson FP. Utility of Electronic Medical Record Alerts to Prevent Drug Nephrotoxicity. Clin J Am Soc Nephrol. 2019 Jan 7;14(1):115-123. doi: 10.2215/CJN.13841217. Epub 2018 Apr 5.

    PubMed 29622668

  • Ahmad T, Freeman JV, Asselbergs FW. Can advanced analytics fix modern medicine's problem of uncertainty, imprecision, and inaccuracy? Eur J Heart Fail. 2019 Jan;21(1):86-89. doi: 10.1002/ejhf.1370. Epub 2018 Dec 10. No abstract available.

    PubMed 30537243

  • Ahmad T, Wilson FP, Desai NR. The Trifecta of Precision Care in Heart Failure: Biology, Biomarkers, and Big Data. J Am Coll Cardiol. 2018 Sep 4;72(10):1091-1094. doi: 10.1016/j.jacc.2018.07.009. No abstract available.

    PubMed 30165979

  • Ahmad T, O'Brien EC, Schulte PJ, Stevens SR, Fiuzat M, Kitzman DW, Adams KF, Kraus WE, Pina IL, Donahue MP, Zannad F, Whellan DJ, O'Connor CM, Felker GM. Evaluation of the Incremental Prognostic Utility of Increasingly Complex Testing in Chronic Heart Failure. Circ Heart Fail. 2015 Jul;8(4):709-16. doi: 10.1161/CIRCHEARTFAILURE.114.001996. Epub 2015 Jun 1.

    PubMed 26034004

  • Seferovic P, Polovina M, Milinkovic I, Krljanac G, Asanin M. Risk stratification models for predicting mortality in heart failure: a favourite or an outsider? Eur J Prev Cardiol. 2024 Jan 25;31(2):272-273. doi: 10.1093/eurjpc/zwac173. No abstract available.

    PubMed 35950368

  • Ahmad T, Desai NR, Yamamoto Y, Biswas A, Ghazi L, Martin M, Simonov M, Dhar R, Hsiao A, Kashyap N, Allen L, Velazquez EJ, Wilson FP. Alerting Clinicians to 1-Year Mortality Risk in Patients Hospitalized With Heart Failure: The REVEAL-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Sep 1;7(9):905-912. doi: 10.1001/jamacardio.2022.2496.

    PubMed 35947362

  • Ahmad T, Yamamoto Y, Biswas A, Ghazi L, Martin M, Simonov M, Hsiao A, Kashyap N, Velazquez EJ, Desai NR, Wilson FP. REVeAL-HF: Design and Rationale of a Pragmatic Randomized Controlled Trial Embedded Within Routine Clinical Practice. JACC Heart Fail. 2021 Jun;9(6):409-419. doi: 10.1016/j.jchf.2021.03.006. Epub 2021 May 12.

    PubMed 33992566

Questions about this trial

What is this clinical trial studying?

A study testing Electronic Alert in people with Heart Failure, run by Yale University at 1 site in United States.

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 1 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: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

All-Cause Mortality (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 NCT03845660, which also lists 8 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 22 Apr 2022.

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