Heart FailureTACITNCT02592135
High Sensitivity cTnT Rules Out Cardiac Insufficiency Trial (TACIT)
An observational study of Heart Failure, run by Indiana University at 5 sites in United States.
Trial summary
The purpose of this study is to better understand myocardial injury in AHF. Secondary analyses demonstrate the prognostic significance of troponin release. The absence of such release has been associated with less risk. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- hsTnT level
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Dec 2015to 31 May 2018
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the Emergency Department (ED) with signs and symptoms of AHF
Who may be able to join
- Age ≥21 years old
- Patient diagnosed with acute heart failure (AHF) by the treating physician.
- Patient has received IV loop diuretic or vasodilator therapy (by any route) for AHF
- Provide informed written consent
- SBP > 100mmHg
Who cannot join
- Life expectancy ≤6 months
- Shock of any kind or use or planned use of inotropes (dobutamine, dopamine, milrinone) or vasopressors. Any form of vasodilator is allowed.
- Fever > 101.5
- Presumed ACS as primary reason for presentation or ACS within 30 days. Patients with troponin release outside of ACS (Type 2 MI) may be included
- AF with RVR > 130bpm at any time requiring medical intervention
- History of transplant of any kind or VAD patient
Show all 11Show fewer
- ESRD requiring dialysis
- Involved in any investigational trial (observational study where there is no intervention is allowed)
- Currently under treatment for cancer of any kind
- Alcohol or other substance abuse
- Any patient whom the investigator deems would be difficult to obtain follow-up
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Cincinnati
Cincinnati, Ohio, 45220
Detroit Receiving Hospital
Detroit, Michigan, 48201
Eskenazi Health
Indianapolis, Indiana, 46202
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Vanderbilt University
Nashville, Tennessee, 37235
About this study
The purpose of this study is to better understand myocardial injury in AHF. Secondary analyses demonstrate the prognostic significance of troponin release. The absence of such release has been associated with less risk. Whether measurement of high sensitivity TnT may enable emergency physicians to better risk stratify acute heart failure patients remains to be determined. This study will help us to better understand the prognostic value of absent or low hsTnT values in the emergency department setting. In addition, we will also test the STRATIFY decision rule; a risk score.
Read the detailed description
Hospitalization for acute heart failure (AHF) results in a high rate of post-discharge mortality and re-admissions, as well as high financial costs. Reducing 30-day re-admissions after AHF hospitalization is a major national quality goal intended to both improve patient outcomes and reduce costs.
Approximately 85% of emergency department (ED) patients with AHF are hospitalized, and 800,000 of the 1,000,000 hospitalizations for HF originate from the ED, highlighting the critical role of the ED. Even a single digit percentage (i.e. 5%) decrease in the number of AHF admissions would equate to an estimated 40,000 fewer hospitalizations.
Why are so many AHF patients hospitalized? AHF patients have a high post-discharge event rate. Emergency physicians have a low risk tolerance. When both are combined, most patients are admitted. The absence of risk scores for the ED setting compounds the problem. Most risk scores were developed in the hospital. As hospitalization may affect the outcomes of patients, whether these risk scores apply to the ED setting is unknown. As a result, which patients are at lower risk in the ED has not been well-studied. Further, absence of high-risk features does not necessarily equal absolute low morbidity or mortality, though such patients are likely at lower risk. In the absence of a risk score, clinical judgment is a poor substitute and often fails to identify patients at high risk, such that those discharged from the ED may be at equal or greater risk for death than hospitalized patients. Thus, the difficulty of identifying low risk, combined with the inherent high morbidity and mortality of AHF, leads to a disproportionate number of hospitalizations.
Over a decade ago, the Agency for Healthcare Research and Policy Guidelines suggested that up to 50% of AHF patients were potential candidates for ED discharge or observation unit management. Furthermore, nearly half of all patients hospitalized for AHF present with lower-risk features such as high blood pressure (> 140mmHg) and a BNP < 1000 pg/mL. If low or lower risk ED patients with HF could be accurately identified, perhaps a greater proportion of patients with AHF could be safely discharged or observed briefly prior to discharge.
Study Rationale: With this pilot study, we will generate the necessary and sufficient pilot data to inform the design of a definitive trial to test whether identification of low risk acute heart failure (AHF) patients with negative serial high-sensitivity troponin T (hsTnT) in the ED may be safely discharged home or observed briefly in observation status.
- Conditions
- Heart Failure
- Being tested
- hsTnT level
- Keywords
- Acute Cardiac Insufficiency, Acute Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hsTnT levelOther
hsTnT and NTproBNP levels at baseline and baseline plus 3 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of all cause mortality and re-hospitalization, including ED re-visits
Have increased the follow up from 30 to 90 days. Will also analyze for 30 days
Measured: 90 days
Secondary outcomes (3)
Days alive and out of hospital
Will also analyze for 30 days
Measured: 90 days
Cardiovascular specific re-hospitalization and ED revisits
Will also analyze for 30 days
Measured: 90 days
Hierarchial Adverse Events Model (STRATIFY Risk Score)
Will also analyze for 30 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start21 Dec 2015
- Primary completion7 Nov 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, Wayne State University, University of Cincinnati
- Responsible party
- Principal investigator, PETER S PANG, Indiana University
- Investigators
- Peter S Pang, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592135
- Sponsor's protocol ID
- INEMER-0001
- Acronym
- TACIT
- Status last verified
- Jun 2018
- First submitted
- 28 Oct 2015
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Pang PS, Fermann GJ, Hunter BR, Levy PD, Lane KA, Li X, Cole M, Collins SP. TACIT (High Sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial). Circ Heart Fail. 2019 Jul;12(7):e005931. doi: 10.1161/CIRCHEARTFAILURE.119.005931. Epub 2019 Jul 10.
PubMed 31288565
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitivity cTnT Rules Out Cardiac Insufficiency Trial (TACIT)
- ClinicalTrials.gov ID
- NCT02592135
- Acronym / sponsor ID
- TACIT / INEMER-0001
- Conditions
- Heart Failure
- Keywords
- Acute Cardiac Insufficiency, Acute Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University, Wayne State University, University of Cincinnati
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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 purpose of this study is to better understand myocardial injury in AHF. Secondary analyses demonstrate the prognostic significance of troponin release. The absence of such release has been associated with less risk. Whether measurement of high sensitivity TnT may enable emergency physicians to better risk stratify acute heart failure patients remains to be determined. This study will help us to better understand the prognostic value of absent or low hsTnT values in the emergency department setting. In addition, we will also test the STRATIFY decision rule; a risk score.
Detailed description
Hospitalization for acute heart failure (AHF) results in a high rate of post-discharge mortality and re-admissions, as well as high financial costs. Reducing 30-day re-admissions after AHF hospitalization is a major national quality goal intended to both improve patient outcomes and reduce costs.
Approximately 85% of emergency department (ED) patients with AHF are hospitalized, and 800,000 of the 1,000,000 hospitalizations for HF originate from the ED, highlighting the critical role of the ED. Even a single digit percentage (i.e. 5%) decrease in the number of AHF admissions would equate to an estimated 40,000 fewer hospitalizations.
Why are so many AHF patients hospitalized? AHF patients have a high post-discharge event rate. Emergency physicians have a low risk tolerance. When both are combined, most patients are admitted. The absence of risk scores for the ED setting compounds the problem. Most risk scores were developed in the hospital. As hospitalization may affect the outcomes of patients, whether these risk scores apply to the ED setting is unknown. As a result, which patients are at lower risk in the ED has not been well-studied. Further, absence of high-risk features does not necessarily equal absolute low morbidity or mortality, though such patients are likely at lower risk. In the absence of a risk score, clinical judgment is a poor substitute and often fails to identify patients at high risk, such that those discharged from the ED may be at equal or greater risk for death than hospitalized patients. Thus, the difficulty of identifying low risk, combined with the inherent high morbidity and mortality of AHF, leads to a disproportionate number of hospitalizations.
Over a decade ago, the Agency for Healthcare Research and Policy Guidelines suggested that up to 50% of AHF patients were potential candidates for ED discharge or observation unit management. Furthermore, nearly half of all patients hospitalized for AHF present with lower-risk features such as high blood pressure (> 140mmHg) and a BNP < 1000 pg/mL. If low or lower risk ED patients with HF could be accurately identified, perhaps a greater proportion of patients with AHF could be safely discharged or observed briefly prior to discharge.
Study Rationale: With this pilot study, we will generate the necessary and sufficient pilot data to inform the design of a definitive trial to test whether identification of low risk acute heart failure (AHF) patients with negative serial high-sensitivity troponin T (hsTnT) in the ED may be safely discharged home or observed briefly in observation status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the Emergency Department (ED) with signs and symptoms of AHF
Key inclusion criteria (5 listed)
- Age ≥21 years old
- Patient diagnosed with acute heart failure (AHF) by the treating physician.
- Patient has received IV loop diuretic or vasodilator therapy (by any route) for AHF
- Provide informed written consent
- SBP > 100mmHg
Key exclusion criteria (11 listed)
- Life expectancy ≤6 months
- Shock of any kind or use or planned use of inotropes (dobutamine, dopamine, milrinone) or vasopressors. Any form of vasodilator is allowed.
- Fever > 101.5
- Presumed ACS as primary reason for presentation or ACS within 30 days. Patients with troponin release outside of ACS (Type 2 MI) may be included
- AF with RVR > 130bpm at any time requiring medical intervention
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 |
|---|---|---|
| hsTnT levelhsTnT and NTproBNP levels at baseline and baseline plus 3 hours. | Other | – |
Primary outcome
A composite of all cause mortality and re-hospitalization, including ED re-visits
Time frame: 90 days
Have increased the follow up from 30 to 90 days. Will also analyze for 30 days
3 secondary outcomes
Days alive and out of hospital
Time frame: 90 days
Cardiovascular specific re-hospitalization and ED revisits
Time frame: 90 days
Hierarchial Adverse Events Model (STRATIFY Risk Score)
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Derived from this study: PubMed 31288565Pang PS, Fermann GJ, Hunter BR, Levy PD, Lane KA, Li X, Cole M, Collins SP. TACIT (High Sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial). Circ Heart Fail. 2019 Jul;12(7):e005931. doi: 10.1161/CIRCHEARTFAILURE.119.005931. Epub 2019 Jul 10.
- Individual participant dataSharing planned: Undecided
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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.
Peter S Pang, MD principal investigator
Indiana University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Indiana University at 5 sites 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 5 inclusion and 11 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 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
A composite of all cause mortality and re-hospitalization, including ED re-visits (time frame: 90 days). 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 NCT02592135, which also lists 1 linked publication.
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 4 Jun 2018.