Hypertension Clinical Trial
Official title:
Pressure Assessment to Improve Outcomes After TAVR: a Registry
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.
Our research has disclosed that patients who have abnormal invasive cardiac hemodynamics
(narrow aortic to ventricular end-diastolic pressure difference, indexed to heart rate) after
TAVR suffer from poor long-term survival. This hemodynamic value can be referred to as the
aortoventricular index (AVi). In a single center observational study, the 2-year mortality
rate for patient with a value ≥0.6 mm Hg/bpm was 25% compared with 36% for patients with a
value <0.6 mm Hg/bpm. An abnormal AVi was an independent predictor for poor survival.
Hypertension and diastolic dysfunction are 2 highly co-morbid conditions among these
patients. Currently, there is lack of appreciation that pressure measurements obtained at the
time of TAVR can provide long-term prognostic value. There is also a lack of understanding on
how to improve outcomes and quality of life among such patients.
Eplerenone is a selective aldosterone receptor antagonist approved for use for treatment of
hypertension. Animal studies have shown that aldosterone receptor antagonists can decrease
interstitial myocardial fibrosis. The non-selective aldosterone receptor antagonist,
spironolactone 25 mg daily compared with placebo was shown to improve diastolic function, as
assessed by echocardiography, among 28 elderly subjects. A meta-analysis of eleven studies in
942 subjects found that aldosterone receptor antagonists improve diastolic function and
markers of cardiac fibrosis without significant changes to left ventricular mass or
dimensions. In a randomized controlled trial, eplerenone was found to be safely tolerated
among asymptomatic patients with moderate to severe aortic stenosis.
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