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临床试验/NCT05219188
NCT05219188Unknown不适用

PErirenal Adipose Tissue and RenaL Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Perirenal fat thickness

研究概览

简要总结

Rationale: Perirenal adipose tissue (PRAT) thickness has been associated to worsening renal function and hypertension. The role of PRAT in heart failure with a preserved ejection fraction (HFpEF) has never been established. The hypothesis of this study is that in patients with HFpEF the diameter of PRAT is increased compared with age, sex and BMI matched controls.

Objective: The main objective is to determine whether PRAT thickness is increased in patients with HFpEF. Secondary objectives are to determine whether PRAT thickness is correlated to whole kidney perfusion, renal venous flow patterns, markers of glomerular and tubular damage and dysfunction, NT pro-BNP, renin and aldosterone. Lastly, this study aims to determine whether these correlations are similar for men and women with HFpEF.

Study design: the proposed study is a single center, cross-sectional observational case-control study, including 30 HFpEF patients and 30 healthy controls.

Study population: Adult patients with HFpEF with a body mass index (BMI) of <25.0 or >30.0 and healthy age, sex and BMI-matched controls.

Intervention (if applicable): Not applicable. Main study parameters/endpoints: The primary endpoint will be the difference in diameter and volume of perirenal adipose tissue measured on dynamic contrast computed CT (DCE-CT) in patients with HFpEF vs. healthy age, sex and BMI matched controls.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating subjects will be asked to visit the University Medical Center Groningen (UMCG) twice (once for screening, once for testing visit). During the testing visit they will undergo intravenous contrast abdominal CT, renal sonography, blood drawing and urine collection. Risks associated with these procedure are very limited, rare and include bleeding and infection for venapunction, and contact dermatitis for ultrasound gel. Adverse events for CT include hypersensitivity reactions to contrast agent, which include skin rash, hypotension and bronchospasm.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

Perirenal fat thickness

时间窗: Up to 28 days after screening

The primary objective is to determine whether perirenal adipose tissue thickness is increased in patients with HFpEF compared with age, sex and BMI-matched healthy controls

次要结局

  • Kidney perfusion(Up to 28 days after screening)
  • Renal venous flow patterns(Up to 28 days after screening)
  • eGFR on CDE-CT(Up to 28 days after screening)
  • Renal biomarkers(Up to 28 days after screening)
  • Heart failure severity(Up to 28 days after screening)
  • Sex differences(Up to 28 days after screening)

研究者

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

A.A.Voors

Principal Investigator

University Medical Center Groningen

研究点 (1)

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