NCT01277679已完成1 期
An Evaluation of MRI Measures of Lung Water Increases With Postural Changes in Healthy Subjects and in Patients With Cardiac Failure: A Methods Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Lung water distribution as measured by MRI
研究概览
简要总结
The aim of this study is to establish a model for the evaluation of drug targets using postural measures to induce changes in lung water concentration as assessed by MRI. A reduction in the magnitude and rate of water transudation with postural changes in patients with congestive heart failure (CHF) could provide a model for the evaluation of various classes of molecules for target validation and for dose selection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Heart Failure Patients:
- •Established diagnosis of mild to moderate heart failure of any aetiology with symptoms defined as corresponding to the New York Heart Association (NYHA) class I, II or III
- •Able in the opinion of the patient and investigator to be supine for 1 hour and to experience passive leg raising (PLR) whilst in the MRI scanner
- •Male or female over 18 years of age at the time of signing the informed consent
- •Negative urine or serum pregnancy test
- •Capable of giving written informed consent
- •Registered with a UK general practitioner.
- •Participants must read (in English) at a level sufficient to adequately complete study related questionnaires
- •Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- •Healthy Volunteers:
- •Healthy as determined by a responsible physician
- •Male or female over 18 years of age at the time of signing the informed consent
- •Capable of giving written informed consent
- •Negative urine or serum pregnancy test
- •Registered with a UK general practitioner
- •Participants must read (in English) at a level sufficient to adequately complete study related questionnaires
- •Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
排除标准
- •Heart Failure Patients
- •History of primary pulmonary disease requiring current medication or other therapy.
- •Orthopnoea of sufficient severity to preclude supine scanning.
- •Hip or leg pathology of sufficient severity to prevent extension of both legs to 45 degrees.
- •Unstable heart failure, defined as change in NYHA status, change in heart failure therapy regimen or hospitalization for acute decompensation of heart failure within preceding 6 weeks.
- •Unstable angina within the past 3 months
- •Current smoker, defined as having smoked in the preceding 1 year
- •Uncontrolled hypertension (resting systolic BP > 160 mmHg or resting diastolic BP > 100mmHg)
- •Resting hypoxia (SaO2 <93%).
- •Contraindication to MRI scanning
- •Pregnant females
- •Positive drugs of abuse or alcohol screen.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •Healthy Volunteers
- •History of primary pulmonary disease requiring current medication or other therapy
- •Current smoker, defined as having smoked in the preceding 1 year
- •Hip or leg pathology of sufficient severity to prevent extension of both legs to 45 degrees
- •Contraindication to MRI scanning
- •Pregnant females
- •Positive drugs of abuse or alcohol screen
- •Unwillingness or inability to follow the procedures outlined in the protocol
研究组 & 干预措施
Healthy Volunteer
Other
Healthy Volunteer cohort
干预措施: MRI (Procedure)
Heart Failure
Other
Heart Failure cohort
干预措施: MRI (Procedure)
结局指标
主要结局
Lung water distribution as measured by MRI
时间窗: Visit 1 and Visit 2 will be approximately 1 week apart
MRI test
Lung water concentration as measured by MRI
时间窗: Visit 1 and Visit 2 will be approximately 1 week apart
MRI test
次要结局
- Between patient variability in lung water concentration as measured by MRI at 2 independent visits(Visit 1 and Visit 2 will be approximately 1 week apart)
- Within patient variability in lung water concentration as measured by MRI at 2 independent visits(Visit 1 and Visit 2 will be approximately 1 week apart)
研究者
研究点 (1)
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