此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype (METAB-HEART)

2021年12月20日 更新者:Assistance Publique - Hôpitaux de Paris
"Little is known about the prevalence, determinants and phenotypes of the cardiomyopathy associated with diabetes and/or metabolic syndrome. The emergence of new therapies (SGLT2 inhibitors) that may mitigate and even prevent the onset of heart failure offers new opportunities.The objective of this protocol is to evaluate the prevalence and phenotypes of cardiomyopathy confirmed by echography in people at high metabolic risk defined as living with diabetes or obesity."

研究概览

地位

尚未招聘

干预/治疗

详细说明

Heart failure (HF) is a frequent disease with a global prevalence of 2.3% that may culminate up to 10% in the elderly. HF is associated with poor outcomes, namely multiple recurrent hospitalizations and high mortality. It is well known for several decades that diabetes is associated with a high cardiovascular mortality, with most physicians initially focusing on coronary artery disease solely. More recently, the concept of specific diabetic and/or metabolic cardiomyopathy emerged with different phenotypes. Obesity and hypertension are highly prevalent in patients with type 2 diabetes (T2D) and several studies have shown similar "diabetic cardiomyopathies" and "obese cardiomyopathies". Congestive HF was found to be two to three times more frequent in patients with T2D than in those without. Asymptomatic HF is underestimated by lack of systematic screening of these patients which prevent them from benefiting from early therapeutics. To our knowledge, no previous study has been made with systematic screening for HF in obese patients without obvious HF signs. Several tools can be used to examine the possible presence of cardiomyopathy and/or HF. The detection of cardiomyopathy at an early, preclinical stage may be of particular interest. First, studies have demonstrated that HF management is more effective at an early stage, with some drugs being associated with a reverse remodeling. Second, the class of SGLT2 inhibitors has proven to reduce the risk of hospitalization for HF in high-risk patients with diabetes.

研究类型

介入性

注册 (预期的)

1500

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults (18 years-old or more)
  • At high metabolic risk: diabetes of any type and/or obesity (body mass index ≥ 30 kg/m²)
  • Admission in the departement of Diabetology-Obesity-Nutrition, Avicenne Hospital, Bobigny, France
  • Patient informed and having signed consent
  • Patient affiliated to a social security scheme or entitled

Exclusion Criteria:

  • Any know cardiac disease: coronary artery disease, heart failure, cardiomyopathy, pulmonary embolism < 6 months, pulmonary hypertension, rhythm disorders < 6 months
  • Blood pressure > 180/110 mmHg
  • Severe renal failure as defined by estimated glomerular filtration rate < 30 ml/min
  • Age ≥ 80 years
  • Previous inclusion in the study
  • Patient under guardianship curatorship
  • Patient on AME (aide médicale d'état)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Biobanking

If the patient consents, two tubes of blood will be collected for biobanking, at the same time as routine tubes will be collected.

Samples will be collected by hospital staff and stored following regulatory conditions of conservation in the biological resources center of Avicenne hospital .

"Collection of blood (One tube of blood 4-5 ml + One EDTA tube of blood 5 ml) will be attempted for each participant at baseline. Availability of these samples will be indicated in the e-CRF.

Samples will be collected by hospital staff and stored following regulatory conditions of conservation in CRB of Hospital Avicenne under the responsibility of Pr Marianne ZIOL. "

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Echographic cardiomyopathy
大体时间:18 months

Echographic cardiomyopathy defined as:

  • Reduced left ventricular ejection fraction (LVEF)<50%, and/or
  • Abnormal diastolic function defined as more than half of positive criteria among: E/e'>14, septal e' velocity<7cm/s or lateral e' velocity<10cm/s, Tricuspid regurgitation (TR) velocity>2.8m/s, indexed left atrial (LA) volume>34ml/m², and/or
  • Isolated left ventricular hypertrophy defined as LV mass ≥115g/m² in male and ≥95g/m² in female
  • Reduced contractility as defined by global longitudinal strain (GLS) < 20%, and/or If clinical sign & symptom, resting ECG and biomarkers are normal, then echography will not be carried out and the cardiomyopathy will be considered absent. "
18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Emmanuel COSSON、Assistance Publique - Hôpitaux de Paris

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年1月15日

初级完成 (预期的)

2022年7月30日

研究完成 (预期的)

2023年9月14日

研究注册日期

首次提交

2021年9月9日

首先提交符合 QC 标准的

2021年12月20日

首次发布 (实际的)

2022年1月6日

研究记录更新

最后更新发布 (实际的)

2022年1月6日

上次提交的符合 QC 标准的更新

2021年12月20日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅