NCT07052539招募中不适用
The Epidemiology and Pathophysiology of Kidney Disease in HFpEF With Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in measured GFR
研究概览
简要总结
This research study wants to learn about Chronic Kidney Disease (CKD) with Obesity, and Heart Failure with preserved Ejection Fraction (HFpEF) and better ways to evaluate these diseases. HFpEF means that the heart is not able to fill properly with blood while it is resting so the amount of blood pumped out to the body is less than it would be if it was filling properly. The study is being done to describe the differences in how the kidneys handle protein and salt in participants with HFpEF and obesity compared to healthy persons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18-75 years old
- •Normal kidney function
- •No heart failure
- •BMI 25-30kg/m2
排除标准
- •Diagnosis of chronic illness
- •eGFR<60mL/min/1.73m2
- •Pregnancy or breast feeding
- •History of cutaneous or allergic reaction to iodine-based products of contrast dyes
- •Hemoglobin levels <7mg/dL
- •Acute illness or hospitalization event within 3 months
- •Unable to stop NSAIDs
- •Comorbid conditions: MM, amyloidosis, pheochromocytoma, SCD, metastatic brain lesions, advanced kidney disease, liver dysfunction, endotoxemia, hyperthyroidism
- •Current use of nicotine or recreational drugs, chronic drinker
- •Criteria for Cohort 2: Obese Participants without HFpEF
- •Inclusion Criteria:
- •Adults 18-75 years old
- •eGFR >= 60 mL/min/1.73m2
- •BMI > 35 kg/m2
- •Exclusion Criteria:
- •Diagnosis of Heart Failure
- •Diagnosis of chronic illness
- •eGFR<60mL/min/1.73m2
- •Pregnancy or breast feeding
- •History of cutaneous or allergic reaction to iodine-based products of contrast dyes
- •Hemoglobin levels <7mg/dL
- •Acute illness or hospitalization event within 3 months
- •Unable to stop NSAIDs
- •Comorbid conditions: MM, amyloidosis, pheochromocytoma, SCD, metastatic brain lesions, advanced kidney disease, liver dysfunction, endotoxemia, hyperthyroidism
- •Current use of nicotine or recreational drugs, chronic drinker
- •Criteria for Cohort 3: HFpEF and Obese Participants
- •Inclusion Criteria:
- •Adults 18-75 years old
- •eGFR >= 60 mL/min/1.73m2
- •BMI > 35 kg/m2
- •Diagnosis of HFpEF (chart diagnosis, LVEF > 55% on echo, H2FPEF score 6-9 or HFA-PEFF score 5 or 6
- •Exclusion Criteria:
- •NYHA class III/IV
- •Urinary retention screen +
- •Mobility issues
- •History of RRT or kidney transplant
- •Acute illness/hospitalization in the past 3 months
- •History of cancer, chemo, or XRT
- •Pregnant/breastfeeding
- •History of allergies to contrast
- •Hemoglobin < 7
- •Comorbid conditions: MM, amyloidosis, pheochromocytoma, SCD, metastatic brain lesions, advanced kidney disease, liver dysfunction, endotoxemia, hyperthyroidism
- •Unable to stop NSAIDs
- •Current use of nicotine or recreational drugs, chronic drinker
结局指标
主要结局
Change in measured GFR
时间窗: 5 hours
Change in urine sodium excretion
时间窗: 5 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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