Evaluation of a revised classification system for advanced heart failure patients.

Study ID
STU 122012-052

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital

Lynn Fernandez

Principal Investigator
Jennifer Thibodeau, M.D.


This is a single-site, investigator-initiated observational, descriptive study that does not involve randomization or placebo/sham procedures that will evaluate the inter-observer agreement, validity, and prognostic ability of a revised nYHa classification system of heart failure. We will enroll adult CHF patients presenting to the uT Southwestern CHF clinic and determine the inter-user agreement of the revised nYHa class assignments between 2 CHF health care providers (nurse practitioners, physicians) at the same visit. additionally, we will collect data including known prognostic markers of heart failure (obtained for clinical purposes) to determine if our revised classification system appropriately identifies patients with increasing severity of illness as determined by presence of these prognostic markers. Finally, we will determine if there is prognostic utility of our revised nYHa classification system for risk of death or need for cardiac transplantation or mechanical circulatory support at one year. We anticipate enrolling at least 200 patients (approximately 5 patients per week). Patients would remain in the study for one year or until death, cardiac transplantation, ventricular assist device implantation, or initiation of inotropic support.

Participant Eligibility

1) Adult (at least 18 years of age) patients with congestive heart failure, defined as left ventricular function <= 45%, seen at the UTSW CHF clinic