High Sensitivity cTnT Rules Out Cardiac Insufficiency Trial (TACIT)

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.

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