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The number of actual events was extremely low. We extended the study period, but it was still not enough. Also, many patients were loss of follow up.
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The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction.
It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases. That is called "cardiorenal syndrome". It was reported that valsartan was effective in reducing the urine albumin extraction rate in patients with hyper- or normotension. We hypothesized that valsartan was more effective to prevent cardiovascular events by the intermediary of improving renal function.
The primary endpoints are:
The secondary endpoints are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan 40mg | Active Comparator | Standard Dose valsartan |
|
| Valsartan 160mg | Active Comparator | High Dose valsartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | valsartan 40 or 160 (80) mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular events | 2 years | |
| End-stage renal dysfunction | 2 years | |
| 50% reduction of creatinine clearance | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| % FS and E/A ratio | 2 years | |
| Specific biochemical markers for cardiac or renal function | 6 months and 1 year and 2 years | |
| % changes of creatinine clearance |
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Inclusion Criteria (all required):
Exclusion Criteria (at least one of following):
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| Name | Affiliation | Role |
|---|---|---|
| Hisao Ogawa, MD, PhD | Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Medicine, Kumamoto University Hospital | Kumamoto | Kumamoto | 860-8556 | Japan | ||
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D059347 | Cardio-Renal Syndrome |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic 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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| 2 years |
| 1/(serum Cr) | 2 years |
| Serum K | 2 years |
| HbA1c | 2 years |
| U-prot/U-Cr | 2 years |
| Adverse drug effects | 2 years |
| New onset Atrial Fibrillation | 2 years |
| Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University |
| Kumamoto |
| 860-8556 |
| Japan |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |