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| Name | Class |
|---|---|
| Tokai University | OTHER |
| Yokohama City University | OTHER |
| Showa University | OTHER |
| Kitasato University |
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The purpose of this study is to prove the hypothesis that the progression of renal and cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker valsartan is added to conventional antihypertensive therapy.
It is widely recognized that suppression of the renin-angiotensin system ameliorates progression of chronic kidney disease (CKD) and that CKD is an important risk factor for development of cardiovascular disease. However, it has not been fully clarified if amelioration of CKD leads to the lower incidence of cardiovascular disease. The purpose of this study is to determine whether the angiotensin II receptor antagonist valsartan, in combination with conventional antihypertensive therapy, will ameliorate progression of both CKD and cardiovascular disease. The primary outcome is courses of renal and cardiac function. The secondary outcome is a composite of a doubling of serum creatinine concentration, end-stage renal disease, myocardial infarction, coronary revascularization, stroke, hospitalization for unstable angina, hospitalization for heart failure or death from cardiovascular causes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Course of renal and cardiac function | every month for renal function and every year for cardiac function |
| Measure | Description | Time Frame |
|---|---|---|
| Doubling of serum creatinine concentration | every month | |
| End-stage renal disease | anytime when it occurs. | |
| Myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenjiro Kimura, MD, PhD | St. Marianna University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Marianna University School of Medicine | Kawasaki | Kanagawa | 216-8511 | Japan |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| St. Marianna University School of Medicine | OTHER |
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| Conventional antihypertensive drugs | Drug | Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers |
|
|
| anytime when it occurs. |
| Coronary revascularization | anytime when it occurs. |
| Stroke | anytime when it occurs |
| Hospitalization for unstable angina | anytime when it occurs. |
| Hospitalization for heart failure | anytime when it occurs. |
| Death from cardiovascular causes | anytime when it occurs. |
| 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 |
| D014652 | Vascular Diseases |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |