跳至主要内容
临床试验/NCT05884346
NCT05884346尚未招募不适用

Association Between Coronary and Peripheral Vascular Injury in Heart Failure Patients With Preserved Ejection Fraction.

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
84
试验地点
2
主要终点
Digital vascular remodeling by ultrahigh-frequency ultrasound

研究概览

简要总结

Heart failure with preserved ejection fraction (HPEF, defined as LVEF ≥50%) represents 50% of hospital admissions for heart failure. Although its morbi-mortality is similar to that of heart failure with reduced ejection fraction (HFPEF), it remains an unknown disease with limited data especially from an etiological point of view. The underlying causes are imperfectly understood, and more than half of the patients have HPEF labeled "idiopathic."

A non-hierarchical clustering study of HPEF patients led to the identification of a subgroup of patients (25%) with a predominant coronary vascular phenotype (i.e., a history of coronary stenosis with or without the need for revascularization). In these patients, vascular endothelial dysfunction would play a central role in the development and progression of heart failure.One of the mechanisms leading to HPEF could be a decrease in the bioavailability of nitric oxide (NO) involved in the relaxation of the cardiac muscle. As the mechanism of action of NO is pleiotropic, a decrease in NO bioavailability could also be observed at the peripheral level, favoring in the long term the development of unfavorable vascular remodeling, for example in the small digital or retinal arteries.Some HPEF patients could thus be distinguished from others by their predominant "vascular" profile. The link between HPEF and endothelial dysfunction has been suspected but never clearly demonstrated.

Ultra-high frequency ultrasound is an innovative technology to estimate the remodeling of small distal arteries in a non-invasive way. The investigators propose to use this imaging on digital arteries in HPEF patients and to study the association with known coronary macrovascular damage.The remodeling parameters will be measured and compared in patients with HPEF with or without identified macrovascular coronary disease.This characterization of arterial remodeling on the digital arteries could be a powerful tool for non-invasive screening in the identification of a subgroup of HPEF that is still considered idiopathic.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(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

结局指标

主要结局

Digital vascular remodeling by ultrahigh-frequency ultrasound

时间窗: Day 1

The wall-to-lumen ratio of digital arteries recorded with ultrahigh-frequency ultrasound.

次要结局

  • Carotid vascular remodeling by echo-tracking(Day 1)
  • Retinal microvascularization(Day 1)
  • Radial vascular remodeling by echo-tracking(Day 1)
  • Endothelial dysfunction(Day 1)
  • Pulse wave velocity(Day 1)
  • Calcium score(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验