NCT02364752撤回1 期
A Clinical Trial to Evaluate Circulating and Imaging Biomarkers in Heart Failure Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Level of total BNP in Part 1
研究概览
简要总结
The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and other circulating biomarker levels, and performs imaging in participants with cardiac dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy participants, biomarker levels are elevated in participants with mild/moderate and severe cardiac dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •female of reproductive potential must demonstrate non-pregnant state, and agree to use two acceptable methods of birth control
- •postmenopausal or surgically sterile female
- •have a Body Mass Index (BMI) >= 18 and =< 35 kg/m^2, inclusive
- •healthy participants are in general good health
- •participants with HF have no untreated, significant health issue from other co-morbidities, e.g. uncontrolled hypertension
- •is willing to undergo echocardiography, CMR, and other study assessments
- •participants with HF have a diagnosis of cardiomyopathy, and slight to moderate limitation of physical activity, but are comfortable at rest
- •participants with HF are on a stable medical therapy for HF for two weeks prior to start of Part 1
- •participants with HF are on a stable diuretic regimen of >= 40 mg/day furosemide or >= 10 mg/day torsemide for at least 2 weeks prior to start of Part 1
排除标准
- •has any clinically significant, uncontrolled renal, endocrine (except Type II Diabetes), neurological, hepatic, immunological or inflammatory disease
- •has a history of cancer (malignancy)
- •had major surgery or donated/lost approximately 500 mL of blood within 4 weeks prior to screening
- •participated in another investigational trial within 4 weeks prior to screening
- •excepting permitted medications, uses prescription, or non-prescription drugs or herbal remedies 2 weeks prior to enrollment until completion of trial
- •takes medications that affect BNP levels within 30 days prior to screening
- •undergoes high-intensity physical exercise from 1 week prior to pretrial visit until completion of trial
- •has implanted or embedded metal objects in body that in response to a magnetic field could cause injury
- •suffers from claustrophobia making them unable to undergo CMR scanning
- •consumes alcohol for 7 days prior to screening until completion of study
- •consumes excessive amounts of caffeinated beverages
- •uses cannabis regularly, or any illicit drugs, or has a history of drug (including alcohol) abuse within prior 12 months
结局指标
主要结局
Level of total BNP in Part 1
时间窗: Up to Day 3
Level of total BNP in Part 2
时间窗: Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)
次要结局
- Level of active BNP in Part 1(Up to Day 3)
- Level of active BNP in Part 2(Up to Day 1 post-loop diuretic withdrawal (Up to Day 10))
- Ratio of total BNP/active BNP in Part 1(Up to Day 3)
- Ratio of total BNP/active BNP in Part 2(Up to Day 1 post-loop diuretic withdrawal (Up to Day 10))
研究者
相似试验
已完成
不适用
Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)Cardiovascular DiseaseCongenital Heart DiseaseNCT00308230Emory University34
终止
1 期
BELIEVE Study: Nesiritide and Post Myocardial Infarction Left Ventricular ModelingMyocardial InfarctionNCT00252213Mayo Clinic24
Unknown
不适用
B-type Natriuretic Peptide Guided Therapy to Improve Clinical Outcomes for Patients Undergoing Non-cardiac SurgerySurgeryCardiovascular ComplicationsRisk AssessmentNCT02679859University of KwaZulu100
已完成
不适用
Do Elevated BNP Levels Predict Hemodynamically Significant PDAsPatent Ductus ArteriosusNCT01497054Albany Medical College109
已完成
不适用
Validation of B-type Natriuretic Peptide With N-terminal Pro B-type Natriuretic Peptide in Perioperative Risk AssessmentPerioperative CareNCT05352698Jordan Leitch466