Pressure Assessment to Improve Outcomes After TAVR: a Registry
Condition: Hypertension; Aortic Stenosis, Calcific; Quality of Life; Heart Failure With Preserved Ejection Fraction
MeSH terms: Aortic Valve Stenosis
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Eplerenone
Intervention type(s): Drug
Intervention description(s): Eplerenone 50 mg daily
Other intervention name(s): Inspra
Intervention MeSH terms: Eplerenone
Intervention model: Single Group Assignment
Intervention model description: Enroll subjects who underwent TAVR and had documentation of abnormal invasive cardiac hemodynamics.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TAVR; KCCQ; Aortic stenosis; Diastolic dysfunction; Invasive hemodynamic assessment