Utility of Dobutamine Stress Echocardiography in the Diagnosis of Severe Aortic Stenosis in Patients With Low-flow Low-gradient and Co-exiting Wild-type Transthyretin Amyloid Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The correlation between echocardiography derived projected aortic valve area (AVAproj) and invasively assessed AVAproj under dobutamine infusion.
研究概览
简要总结
The goal of this prospective clinical study is to improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt). The main question it aims to answer is whether the classic dobutamine-stress echocardiography can be used to determine AS severity in patients with ATTRwt and LF/LG AS. We will do that by comparing dobutamine stress echocardiography, with the invasively measured aortic valve area (which is considered as the gold standard).
In addition we aim to assess the degree of myocardial fibrosis and amyloid infiltration, assessed by light microscopy and cardiac magnetic resonance (CMRI) and evaluation of myocyte mitochondrial function by high resolution respirometry and their relation to AS severity and hemodynamic response to dobutamine.
详细描述
Study protocol
A- Baseline assessment: The following will be measured:
- Blood pressure and heart rate.
- ECG.
- Standard echocardiography.
- Dobutamine stress echocardiography.
B- Catheterization laboratory: The participant will be transferred to the catheterization laboratory after about 1.5-hour recovery period after the end of dobutamine stress echocardiography. The following will be done in the following order:
- Right heart catheterization and endomyocardial biopsies.
- Left heart catheterization.
- Dobutamine challenge: Infusion of increasing dobutamine dosages, with simultaneous invasive measurements.
- Removal of left and right heart catheters: The catheters will be removed after 5 minutes recovery after dobutamine challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ATTRwt, diagnosis confirmed by 99mtc-3,3-Diphosphono-1,2-Propanodicarboxylic Acid (DPD) scintigraphy, genetic testing, and/or endomyocardial biopsy.
- •Symptomatic patients (New York Heart Association > class I) treated with loop diuretics.
- •LF/LG AS: Defined as, aortic valve area ≤ 1 cm2 and mean gradient < 40 mmHg, and SVI ≤35 ml/m
- •Age ≥ 65 years.
- •Oral and written informed consent.
排除标准
- •Other significant valvular disease.
- •Known severe coronary artery diseases: left main stem stenosis or 3-vessel disease, or recent acute myocardial infarction (< 4 weeks).
- •Contraindications to the use of dobutamine: Known allergy to dobutamine or sulfite, phaeochromocytoma or ventricular tachycardia (VT).
研究组 & 干预措施
Co-existing AS and ATTRwt
Symptomatic patients with co-existing wild-type transthyretin amyloid cardiomyopathy and low-flow low gradient AS.
干预措施: Dobutamine stress echocardiography (Diagnostic Test)
结局指标
主要结局
The correlation between echocardiography derived projected aortic valve area (AVAproj) and invasively assessed AVAproj under dobutamine infusion.
时间窗: Evaluated at the end of dobutamine infusion.
次要结局
- Correlation between echocardiography derived AVA and invasively assessed AVA at rest and at different dobutamine infusion levels.(Evaluated at rest, at every dobutamine dose-level, and at the end of infusion.)
- Correlation between echo- and invasive measured SVI.(Evaluated at the end of dobutamine infusion.)
- Increase of SVI, LV ejection fraction and LV-global longitudinal strain of 10 % during maximal dobutamine stimulation.(Evaluated at the end of dobutamine infusion.)
- Complication rate and symptomatic side effects during dobutamine challenge(Evaluated after couple of days after trial day with dobutamine infusion.)
- Degree of myocardial fibrosis, amyloid infiltration and mitochondrial dysfunction and its relation to AS severity and hemodynamic response to dobutamine(CMRI would be performed within a max of 2 months from the trial day.)
- Reduction of mean pulmonary artery wedge pressure and/or mean pulmonary artery pressure by 10 %.(Evaluated at the end of dobutamine infusion.)
研究者
Steen Hvitfeldt Poulsen
Professor, DMSc.
Aarhus University Hospital Skejby