Pressure Assessment to Improve Outcomes After TAVR: a Registry
Status:
Completed
Trial end date:
2020-02-27
Target enrollment:
Participant gender:
Summary
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures
are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures. Our
research has disclosed that patients with abnormal hemodynamics (narrow aortic to ventricular
end-diastolic pressure difference, indexed to heart rate) suffer from high long-term
mortality, compared with patients with normal hemodynamics.This hemodynamic value can be
referred to as the aortoventricular index (AVi). Hypertension and diastolic dysfunction are
highly co-morbid conditions among these patients. The selective aldosterone receptor
antagonist eplerenone (Inspra) is approved for use in the treatment of hypertension. Research
also supports that eplerenone may be able to improve diastolic function.
This prospective study is interested in determining 1) the tolerability of eplerenone, and 2)
feasibility of administering the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) among
subject with abnormal cardiac hemodynamics after TAVR. This study will set the stage for a
pilot randomized trial to evaluate eplerenone versus placebo among patients with abnormal
hemodynamics after TAVR.
Phase:
Early Phase 1
Details
Lead Sponsor:
North Florida Foundation for Research and Education