High Sensitivity cTnT Rules Out Cardiac Insufficiency Trial (TACIT)

Heart Failure Clinical Trial

— TACIT  

Official title:

High Sensitivity cTnT Rules Out Cardiac Insufficiency Trial (TACIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592135
• Other study ID #: INEMER-0001
• Status: Completed
• Start date: December 21, 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 31, 2018
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• hsTnT level
hsTnT and NTproBNP levels at baseline and baseline plus 3 hours.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Detroit Receiving Hospital	Detroit	Michigan
United States	Eskenazi Health	Indianapolis	Indiana
United States	IU Health Methodist Hospital	Indianapolis	Indiana
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	University of Cincinnati, Vanderbilt University, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days
Secondary	Days alive and out of hospital	Will also analyze for 30 days	90 days
Secondary	Cardiovascular specific re-hospitalization and ED revisits	Will also analyze for 30 days	90 days
Secondary	Hierarchial Adverse Events Model (STRATIFY Risk Score)	Will also analyze for 30 days	90 days