ISRCTN10318149已完成未知
Effect of Valsartan in Ventricular Function and Aortic Elasticity
Beth Israel Deaconess Medical Centre (USA)0 个研究点目标入组 24 人开始时间: 2006年5月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
2009 results in https://pubmed.ncbi.nlm.nih.gov/19375592/ (added 11/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •We plan to study two groups with 15 subjects each:
- •1. Healthy non-diabetic subjects
- •2. Patients with type 2 diabetes with no severe long-term diabetes complications
- •For inclusion in the trial, patients must fulfil all of the following criteria:
- •1. All subjects will be ages 21-80 years
- •2. Healthy subjects - subjects should not be considered at higher risk than the general population to develop type 2 diabetes according to one of the following criteria:
- •a. Fasting plasma glucose <100 mg/dl and/or a 2-hour plasma glucose <140 during 75 gm oral glucose tolerance test (OGTT)
- •3. Patients with type 2 diabetes with no serious long-term complications
- •4. Individuals with a diagnosis of type 2 diabetes according to the American Diabetes Association criteria below, established in 1998. Subjects previously diagnosed with type 2 diabetes will not require a repeated diagnostic testing.
- •a. Unequivocal elevated plasma glucose level >200 mg/dl with symptoms suggestive of hyperglycemia (polyuria, polydipsia, weight loss)
- •b. Fasting plasma glucose levels >126 mg/dl
- •c. Two-hour plasma glucose >200 mg/dl during a 75 gm OGTT
- •In the absence of unequivocal hyperglycemia with acute metabolic decompensation, these criteria should be confirmed by repeat testing on a different day.
- •5. Prior to participation in this study, each subject must sign an informed consent form
排除标准
- •Active or uncontrolled cardiovascular disease as follows:
- •a. Coronary artery disease (CAD) (known CAD with previous diagnosis of definite acute myocardial infarction, unstable angina or stable angina)
- •b. Arrhythmia (uncontrolled, highly symptomatic, requires treatment or life-threatening)
- •c. Congestive heart failure (CHF) (New York Heart Association function class III and IV - symptoms of heart failure on less than ordinary exertion or at rest)
- •d. Stroke or transient ischemic attack with residual neurological damage
- •e. Uncontrolled hypertension: systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >105 mmHg (two abnormal readings during visit)
- •f. Hypotension
- •2. Liver disease (alanine aminotranferease (ALT), aspartate aminotransferase (AST), alkaline phosphate levels >2 times upper normal limit) at the time of enrolment
- •3. Renal disease (macro-albuminuria) (2 of 3 urine specimens collected within a 3-6 month period with urine albumin =300 ug/mg creatinine - according to the American Diabetes Association (ADA) position statement)
- •4. Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl). Subjects with hypertriglyceridemia may be re-tested in 2-3 weeks as the values can fluctuate tremendously within a few days. In the event that the re-tested value allows the patient to be enrolled, a planned deviation will be submitted to the Cardiovascular Credentialing International (CCI).
- •5. Any other serious chronic disease requiring active treatment
- •6. Females of childbearing potential not using an effective form of birth control as determined by the investigators
- •7. Subjects on any of the following medications:
- •a. Angiotensin II receptor antagonist treatment during last 3 months
- •b. Systemic glucocorticoids
- •c. Antineoplastic agents
- •d. Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis
- •8. Claustrophobia
- •9. Subjects unable to have magnetic resonance imaging (MRI) scan according to the MRI clinical standards such as a pacemaker, defibrillator, eye implants and other metal implants or devices
研究者
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