Evaluation of Kidney Medullary Sodium Content Using 23Na MRI to Understand and Predict Diuretic Resistance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Medullary sodium concentration
研究概览
简要总结
Diuretic therapy is the cornerstone of the management of fluid overload in heart failure. Resistance to diuretic therapy is the most common reason for treatment failure in patients affected by the combination of heart failure and kidney disease. Currently, there is no way of predicting whether heart failure patients will develop resistance to diuretic therapy and what dose of diuretic is necessary to overcome diuretic resistance. Answering these questions would allow doctors to be able to prescribe an accurate dose of diuretic therapy to prevent diuretic resistance and potential side effects of an excessive diuretic dose.
With magnetic resonance imaging, it is possible to measure the kidney sodium (salt) content and observe the diuretic response in patients with heart failure and kidney disease. The investigators speculate that measuring kidney sodium content will allow to predict diuretic response in these patients.
The aim of this study is to compare the kidney sodium content in patients with chronic cardiorenal syndrome with and without diuretic resistance. Secondly, in a sample of patients with diagnosed diuretic resistance,the aim will be to observe the changes in kidney sodium content induced by an additional dose of diuretic therapy and to observe whether these changes are associated with a response to diuretic therapy.
详细描述
This is a prospective, interventional, pilot study involving patients recruited from the Heart Failure outpatient clinic at St. Joseph's Hospital in London, Ontario. Depending on scanner availability, the study visits may also take place at Robarts Research Institute, University of Western Ontario. All eligible patients who consent to take part in the study will undergo one study visit. During this visit, all study participants will undergo a combined proton (1H) and 23Na MRI scan of their kidneys to measure kidney sodium content. Prior to the scan, all participants will be asked to complete a questionnaire, will have their fluid volume measured using bioimpedance spectroscopy, will have their heart failure classified using the NYHA system, will have their weight taken using a clinical scale, and will have their sitting blood pressure and heart rate measured three times consecutively using a standard automatic blood pressure monitor. In addition to this, all participants will undergo a research focused echocardiogram, provide a spot urine sample and have blood work collected. All participants will be responsible to complete a 24-hour urine volume test the day before the study visit and bring the special container to the team on the visit day.
Study participants who meet the criteria for diuretic resistance will undergo a second study visit within one week of the first one. During this visit, participants will receive an additional intravenous dose of diuretic (furosemide) and they will subsequently undergo a second proton and 23Na MRI scan of their kidneys. Prior to the scan participants will undergo the same study procedures as in visit one excluding the questionnaire. In addition to this, participants will be responsible to record their weight at home the morning before the visit and bring their weight to the study team. After the scan, all participants will have their blood pressure, heart, rate, and weight measured again, and will be asked to complete a 24-hour urine collection. Furthermore, participants will be asked to take their weight using a home scale the morning after the scan and a member of the research team will phone the participants to collect this information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •for Visit 1
- •Clinico-pathological diagnosis of heart failure
- •Age ≥ 18 years
- •Estimated GFR ≥ 15 mL/min/1.73m2
- •Receiving loop diuretics for at least a week at ≥ 40 mg/day (furosemide) or 2 mg/day (bumetanide), either orally or intravenously
- •Willing and able to provide consent
- •Inclusion Criteria for Visit 2 · Patients from visit 1 with diuretic resistance
排除标准
- •for Visit 1 Direct contraindications to MR scanning (implanted materials etc.)
- •Additional diuretic types other than spironolactone/epleronone/metolazone/finerenone
- •Liver disease with hepato-renal syndrome
- •Pregnant, breastfeeding or intending pregnancy
- •Kidney malformation leading to chronic kidney disease (for example polycystic kidney)
- •Unable to provide consent
- •Exclusion criteria for Visit 2
- •· Hypokalemia (serum potassium <3.5 mmol/l)
研究组 & 干预措施
Furosemide Injection
Patients with diuretic resistance:
The presence of diuretic resistance, defined as having clinical signs of fluid overload despite diuretic therapy (this information is routinely collected at each clinical visit). "Fluid overload" is defined as the presence of at least two of the following clinical features:
- Peripheral or sacral oedema
- Jugular venous distension ≥ 7 cm
- Radiographic pulmonary oedema or pleural effusion
- Enlarged liver or ascites
- Pulmonary rales, paroxysmal nocturnal dyspnoea, or orthopnoea
- Point of Care UltraSound (POCUS) evidence of congestion. Inferior Vena Cava diameter >2.5 cm and/or failure to collapse at least 50% with sharp inspiration
干预措施: Furosemide Injection (Drug)
结局指标
主要结局
Medullary sodium concentration
时间窗: Through MRI, an average of 60 minutes
To demonstrate a statistically significant difference in medullary sodium concentration of at least 100 mmol/L between patients with chronic cardiorenal syndrome who are responsive versus patients who are resistant to their current diuretic therapy.
次要结局
- Change in medullary sodium concentration(Through MRI, an average of 60 minutes)
- Change in corticomedullary sodium gradient(Through MRI, an average of 60 minutes)
- Corticomedullary sodium gradient(Through MRI, an average of 60 minutes)
- Correlation between kidney sodium content and renal function(Through one study visit, and average of 3 hours)
- Correlation between kidney sodium content and inflammation(Through one study visit, and average of 3 hours)
- Correlation between kidney sodium content and Bioimpedance spectroscopy(Through one study visit, an average of 3 hours)
- Correlation between kidney sodium content and NYHA(Through one study visit, an average of 3 hours)
- Correlation between kidney sodium content and echocardiography(Through one study visit, an average of 3 hours)
- Correlation between kidney sodium content and biological cardiac biomarker(Through one study visit, and average of 3 hours)
研究者
Chris McIntyre
Professor of Medicine, Medical Biophysics and Pediatrics
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's