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临床试验/NCT03923530
NCT03923530已完成早期 1 期

Pressure Assessment to Improve Outcomes After TAVR: a Registry

North Florida Foundation for Research and Education1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年6月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Summary Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Eplerenone

Experimental

Eplerenone 50 mg daily, administered orally for 8 weeks.

干预措施: Eplerenone (Drug)

结局指标

主要结局

Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Summary Score

时间窗: Baseline, 8 weeks

The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered health status survey. The KCCQ-12 has 4 domains (physical limitation, symptom frequency, quality of life, social limitation) and one summary score. Score are scaled 0-100, where 1 denotes the lowest reportable health status and 100 the highest.

次要结局

  • Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Physical Limitation Score(Baseline, 8 weeks)
  • Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Symptom Frequency Score(Baseline, 8 weeks)
  • Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Quality of Life Score(Baseline, 8 weeks)
  • Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Social Limitation Score(Baseline, 8 weeks)
  • Systolic Blood Pressure(Baseline, 8 weeks)
  • Diastolic Blood Pressure(Baseline, 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony Bavry

Director of Cardiovascular Catheterization Laboratory

North Florida Foundation for Research and Education

研究点 (1)

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