NL-OMON52103招募中不适用
PErirenal Adipose tissue and RenaL hemodynamics in patients with Heart Failure with Preserved Ejection Fraction - PEARL-HFPEF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
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 99（—）
入选标准
- •4.1 Inclusion criteria (patient category):
- •1. Able and willing to give written informed consent
- •2. Male and female subjects with age >18 years
- •3. A diagnosis of HFpEF based on typical symptoms (and/or signs), a LVEF >50%
- •(assessed within 12 months prior to baseline testing) and at least two of the
- •following criteria10:
- •a. For BMI <35.0 kg/m2: NT pro-BNP >=220 pg/mL
- •For BMI >=35.0 kg/m2: NT pro-BNP >=125 pg/mL
- •b. Left atrial volume index >34 ml/m2 or Left ventricular mass index >115g/m2
- •(men) or >95g/m2 (women)
- •c. E/e* >=13 or e* average <9 cm/s
- •4. BMI <25 or >30
- •Inclusion criteria for healthy controls:
- •1. Able and willing to give written informed consent
- •2. Male and female subjects with age >18 years
- •3. BMI <25 of >30
排除标准
- •Exclusion criteria for patient category:
- •1. Amyloid cardiomyopathy or cardiomyopathy due to sarcoïdosis or M. Fabry, as
- •reflected by medical history.
- •2. Genetic hypertrophic (obstructive) cardiomyopathy.
- •3. Severe (grade III/III) aortic stenosis.
- •4. Female patient with childbearing potential, aiming to get pregnant or
- •pregnant at the time of inclusion.
- •6. Patients on (intermittent or continuous) hemodialysis
- •7. Proven hypersensitivity to iodine contrast, or any other contra-indication
- •for CT diagnostics
- •Exclusion criteria for healthy controls:
- •1. Diagnosis of any cardiovascular disease, either in the medical history or
- •diagnosed during screening.
- •2. Diagnosis of diabetes mellitus, defined as use of glucose lowering drugs
- •3. Diagnosis of hypertension, defined as mean of 3 blood pressures measurements
- •of >140/90 mmHg at screening or use of blood pressure lowering drugs.
- •4. Female patients with childbearing potential, either already pregnant or
- •aiming to get pregnant at the time of inclusion.
- •5. Proven hypersensitivity to iodine contrast or any other contra-indication
- •for CT diagnostics
研究者
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