NL-OMON52382招募中不适用
CARdiomyopathy in type 2 DIAbetes mellitus - CARDIATEAM
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •* Female or male, aged between >= 40 and <=80 years
- •* Normal LVEF AND absence of akinetic segment assessed by echocardiography
- •(i.e. LVEF>=50%)
- •* For each group, the diagnosis will be based on current accepted criteria [7,
- •o HFpEF: left ventricular ejection fraction (LVEF) LVEF>=50% AND presence/or
- •history of symptoms (e.g. breathlessness, ankle swelling and fatigue) or signs
- •(e.g. elevated jugular venous pressure, pulmonary crackles and peripheral
- •oedema) of heart failure AND significant diastolic dysfunction (left atrial
- •volume index >34 mL/m2 or a LVMI >=115 g/m2 for males and >=95 g/m2 for female,
- •E/e* >=13 and e* <9 cm/s) OR NT-proBNP >125 pg/mL
- •o No HFpEF: LVEF>=50% AND absence of symptoms (e.g. breathlessness, ankle
- •swelling and fatigue) or signs (e.g. elevated jugular venous pressure,
- •pulmonary crackles and peripheral oedema) of heart failure
- •o T2DM: HbA1c >=6.5% (>=48 mmol/L) AND Fasting Plasma Glucose >=7.0 mmol/L (>=126
- •mg/dL) or anti-diabetic treatment
- •o Non T2DM: HbA1c < 6.5% AND Fasting Plasma Glucose <7.0 mmol/L without any
- •anti-diabetic treatment including normoglycemic subjects
- •o HCM: patients with non-obstructive HCM of sarcomeric cause (proven with
- •common genetic cause) and with LV wall thickness >= 15 mm in one or more
- •myocardial segments in the absence of abnormal afterload conditions.
- •* Suitable echocardiographic window
- •* Absence of history of coronary artery disease including history of myocardial
- •ischaemia, myocardial infarction or percutaneous coronary intervention
- •* Absence of significant coronary artery disease (CAD) defined as
- •o the absence of coronary artery stenosis >=50% on a cardiac computed tomography
- •(CT) OR a coronary angiography OR normal Fractional Flow Reserve (FFR >0.80) OR
- •Coronary Artery Calcium score (CAC) < 100 performed within the 24 months before
- •inclusion. Coronary CT and/or stress tests will not be performed as part of the
- •study in the Dutch centers. Only patient in which the absence of CAD has
- •previously been confirmed by this definition (due to clinical indication) will
- •be included.
- •* Patient covered by a health insurance
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •* Diabetes mellitus other than type 2 (type 1, LADA, MODY, NODAT, etc.)
- •* Suboptimal echocardiographic window
- •* Significant valvular heart disease defined as severe aortic regurgitation or
- •severe primary mitral regurgitation or aortic stenosis with a peak
- •transvalvular velocity >=3m/s or mitral stenosis with a mitral valve area <
- •* Chronic atrial fibrillation or any significant arrhythmia at inclusion
- •* Renal insufficiency defined as eGFR<30 mL/min/1.73m²
- •* History of and candidate to bariatric surgery
- •* Obstructive hypertrophic cardiomyopathy (definition: maximal gradient at rest
- •* Hypertrophic cardiomyopathy due to a non-sarcomeric etiology, i.e. known
- •infiltrative or storage disorder mimicking HCM such as Fabry disease or
- •amyloidosis
- •* Life threatening comorbidities (i.e. history of or active cancer treated with
- •chemo-therapy or radiotherapy, end-stage heart failure, severe lung disease,
- •* Pregnancy
- •* Lactating mother.
- •* Any condition which in the Investigator*s opinion makes it undesirable for
- •the subject to participate in the study or which would jeopardize compliance
- •with the protocol (e.g. known contrast allergy)
- •* Inability to understand the local language
- •* Individuals deprived of liberty
- •* Protected persons (under guardianship or curatorship)
- •* Contra-indication to CMR (please see CMR_SOP)
- •* Known hypersensitivity to gandolinium based product (including gadoteric acid
- •and meglumine)
- •* Known symptomatic COVID-19 infection requiring hospitalization.
研究者
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