Clinical trial NCT02592135: High Sensitivity cTnT Rules Out Cardiac Insufficiency Trial (TACIT)
Official title: High Sensitivity cTnT Rules Out Cardiac Insufficiency Trial (TACIT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Acute Cardiac Insufficiency
Acute Heart Failure
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: Wayne State University
name: University of Cincinnati
First posted: 2015-10-30
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the Emergency Department (ED) with signs and symptoms of AHF

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥21 years old
2. Patient diagnosed with acute heart failure (AHF) by the treating physician.
3. Patient has received IV loop diuretic or vasodilator therapy (by any route) for AHF
4. Provide informed written consent
5. SBP \> 100mmHg

Exclusion Criteria:

1. Life expectancy ≤6 months
2. Shock of any kind or use or planned use of inotropes (dobutamine, dopamine, milrinone) or vasopressors. Any form of vasodilator is allowed.
3. Fever \> 101.5
4. 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
5. AF with RVR \> 130bpm at any time requiring medical intervention
6. History of transplant of any kind or VAD patient
7. ESRD requiring dialysis
8. Involved in any investigational trial (observational study where there is no intervention is allowed)
9. Currently under treatment for cancer of any kind
10. Alcohol or other substance abuse
11. Any patient whom the investigator deems would be difficult to obtain follow-up

Primary outcomes:
measure: A composite of all cause mortality and re-hospitalization, including ED re-visits
timeFrame: 90 days
Secondary outcomes:
measure: Days alive and out of hospital
timeFrame: 90 days
measure: Cardiovascular specific re-hospitalization and ED revisits
timeFrame: 90 days
measure: Hierarchial Adverse Events Model (STRATIFY Risk Score)
timeFrame: 90 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Indiana University
name: Peter S Pang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.