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| Name | Class |
|---|---|
| Japan Foundation for Aging and Health | OTHER |
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The present research is conducted as a randomized, parallel-group, controlled, open study (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition, onset of cardiovascular events and levels of markers that are associated with cardiovascular events are observed over time to examine the significance of each marker. The biomarkers will be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from the start of the study.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-ARB group | Active Comparator |
| |
| ARB group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-ARB (standard therapy) | Drug | Blood pressure lowering therapy except ARB |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of ARB therapy and that of standard therapy except ARB on the biomarker levels (UACR and BNP) | for three years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
Outpatients
Age: ≥ 40 to < 80
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.
Patients who have given consent to participate in the present study.
Cardiovascular risks:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Hisao Ogawa, Prof., MD, PhD | Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | Study Chair |
| Shokei Kim-Mitsuyama, Prof., MD, PhD | Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University | Study Director |
| Koichi Node, Prof, MD, PhD | Department of Cardiovascular and Renal Medicine, Saga University Faculty of Medicine | Study Director |
| Hirofumi Soejima, MD, PhD | Health Care Center / Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | Principal Investigator |
| Osamu Yasuda, MD, PhD | Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital | Kumamoto | 860-8555 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26324672 | Background | Ogawa H, Soejima H, Matsui K, Kim-Mitsuyama S, Yasuda O, Node K, Yamamuro M, Yamamoto E, Kataoka K, Jinnouchi H, Sekigami T; ATTEMPT-CVD investigators. A trial of telmisartan prevention of cardiovascular diseases (ATTEMPT-CVD): Biomarker study. Eur J Prev Cardiol. 2016 Jun;23(9):913-21. doi: 10.1177/2047487315603221. Epub 2015 Aug 31. | |
| 33046765 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D002561 | Cerebrovascular Disorders |
| D003324 | Coronary Artery Disease |
| D051436 | Renal Insufficiency, Chronic |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| ARB (Telmisartan) |
| Drug |
Telmisartan 20-80 mg/day |
|
| Kim-Mitsuyama S, Soejima H, Yasuda O, Node K, Jinnouchi H, Yamamoto E, Sekigami T, Ogawa H, Matsui K. Reduction in hsCRP levels is associated with decreased incidence of cardiovascular events in Japanese hypertensive women but not in men. Sci Rep. 2020 Oct 12;10(1):17040. doi: 10.1038/s41598-020-73905-4. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |