A Trial of Telmisartan Prevention of Cardiovascular Disease
Клучни зборови
Апстракт
Опис
Events are defined as follows; Cerebrovascular events: Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke), transient ischemic attack Coronary events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia Cardiac events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia, heart failure Aortic/peripheral arterial events: Aortic aneurysm, aortic dissection, arteriosclerotic disease (aorta, carotid artery, renal artery, mesenteric artery, peripheral artery, etc.) Complications of diabetes: Diabetic nephropathy*, diabetic retinopathy*, diabetic neuropathy* Aggravation of renal function: Doubling of serum creatinine level, ESRD (initiation of dialysis, renal transplantation)
*Newly occurred or aggravated
The followings will be measured as biomarkers; urinary albumin creatinine rates (UACR), plasma brain natriuretic peptide (BNP), urinary 8-hydroxy-deoxy-guanosine (8-OHdG), serum adiponectin, serum high-molecular weight adiponectin, high sensitivity c-reactive protein (hsCRP), estimated glomerular filtration rate (eGFR)
Датуми
| Последен пат проверено: | 08/31/2016 |
| Прво доставено: | 02/23/2010 |
| Поднесено е проценето запишување: | 02/23/2010 |
| Прво објавено: | 02/24/2010 |
| Последното ажурирање е доставено: | 09/02/2016 |
| Последно ажурирање објавено: | 09/06/2016 |
| Крај на датумот на започнување на студијата: | 06/30/2009 |
| Проценет датум на примарно завршување: | 01/31/2015 |
| Проценет датум на завршување на студијата: | 02/29/2016 |
Состојба или болест
Интервенција / третман
Drug: Non-ARB group
Drug: ARB group
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Active Comparator: Non-ARB group | Drug: Non-ARB group Blood pressure lowering therapy except ARB |
| Active Comparator: ARB group | Drug: ARB group Telmisartan 20-80 mg/day |
Критериуми за подобност
| Возраст подобни за студии | 40 Years До 40 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: Patients who meet all of the criteria listed in [1] to [4] below and who have at least one cardiovascular risk listed in [1] to [5] below will be included in the study. 1. Outpatients 2. Age: ≥ 40 to < 80 3. Hypertension: Systolic blood pressure of ≥ 140 mmHg or diastolic blood pressure of ≥ 90 mmHg in the two latest measurements of casual blood pressure (in the sitting position) regardless of treated or untreated condition, or systolic blood pressure of < 140 mmHg and diastolic blood pressure of < 90 mmHg that require antihypertensive treatment. Assessment of hypertension: Blood pressure will be measured at least twice at an interval of 1 to 2 minutes. If the measured values obtained are substantially different, additional measurements will be performed and the average of two stable measurements will be used for assessment. 4. Patients who have given consent to participate in the present study. Cardiovascular risks: 1. Diabetes mellitus; Type 2 diabetes mellitus 2. Kidney; Serum creatinine: 1.2 mg/dL - < 2.0 mg/dL for males, 1.0 mg/dL - < 2.0 mg/dL for females Proteinuria: qualitative value of ≥ +1 (quantitative value: proteinuria with the value of ≥ 0.3 g/g・Cr in casual urine when adjusted with urine creatinine) CKD stage 3 or higher (GFR < 60 mL/min/1.73 m2) 3. Heart; Previous myocardial infarction noted more than 6 months before obtaining the informed consent Diagnosis of angina pectoris Diagnosis of heart failure (NYHA I or II class) Diagnosis of left ventricular hypertrophy (left ventricular posterior wall of ≥ 12 mm evidenced by echocardiography performed prior to obtaining the informed consent, or Sv1+Rv5 of ≥ 35 mm noted as ECG finding) Diagnosis of transient or persisting atrial fibrillation 4. Brain; Previous cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient cerebral ischemic attack noted more than 6 months before obtaining the informed consent 5. Peripheral arterial diseases; Previous lower-limb bypass surgery or angioplasty performed more than 6 months before obtaining the informed consent Ankle-brachial pressure index of < 0.9 or intermittent claudication Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study. 1. Type 1 diabetes mellitus 2. Severe renal disorders (serum creatinine of ≥ 2.0 mg/dL) 3. Myocardial infarction, percutaneous transluminal angioplasty and bypass surgery of coronary artery/ lower-limb blood vessel, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage and transient cerebral ischemic attack noted within 6 months before initiation of the observation 4. Diagnosis of heart failure (NYHA III or IV class ) 5. Virulent hypertension and secondary hypertension 6. Pregnant women 7. Clinically relevant allergic symptoms or past history of hypersensitivity to drugs / significant adverse drug reactions 8. Extremely poor bile secretion or serious liver disorders 9. Treatment-required malignant tumors 10. Patients who are judged by the physician in charge to be ineligible for the study for any other reasons |
Исход
Мерки на примарниот исход
1. The effects of ARB therapy and that of standard therapy except ARB on the biomarker levels (UACR and BNP) [for three years]
Секундарни мерки на исходот
1. The effect of the two treatments on the incidence of events, and the relationship between the incidence of events and the biomarker levels (UACR, BNP, urine 8-hydroxy-2-deoxyguanosine, serum adiponectin, serum high-molecule adiponectin, eGFR) [for three years]
