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| ID | Type | Description | Link |
|---|---|---|---|
| TOR-IIT-001 | Other Grant/Funding Number | Investigator Initiated study. Grant was provided by Takeda Pharmaceuticals LLC, Russia |
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Study hypothesis is that the time from randomization to the increase of natriuresis (%), time to standardization of natriuresis daily profile, blood pressure profile and the percentage reduction of central hemodynamic parameters will be relatively changed over the study period by more than 15%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged release Torasemide (Britomar) | Experimental | Prolonged release Torasemide (Britomar) - round, biconvex, white to off-white tablets debossed SN with one side. 1 tablet contains active substance - torasemide 5 or 10 mg and excipients - guar gum, maize starch, anhydrous colloidal silica, magnesium stearate, lactose. Dosage scheme: per os, once a day, regardless of meals. The common starting dose in CHF - 10-20 mg once a day. If adequate diuretic effect is absent, the dose is increased approximately twofold up to adequate diuretic effect. |
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| Torasemide (Diuver) | Active Comparator | Torasemide (Diuver) - white to off-white, round, biconvex tablets. 1 tablet contain active substance - torasemide 5 or 10 mg and excipients - lactose monohydrate, maize starch, sodium glycolate starch, anhydrous colloidal silica, magnesium stearate. Dosage scheme: per os, once a day, after meals. Therapeutic dose - 5 mg a day. If necessary, a dose may be increased up to 20 mg a day, in some cases - up to 40 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged release Torasemide (Britomar) | Drug |
| ||
| Torasemide (Diuver) |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers excretion | 15% or more increasing of the following Tamm-Horsfall protein, beta-2-microglobulin, osteoponin, TGF- β1 excretion in comperison with baseline level | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Daily sodium excretion | Increasing of daily sodium excretion on 30% or more in comparison with baseline | 3 months |
| Augmentation index | Decreasing of augmentation index on 30 or more percents in comparison with baseline level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grigory P Arutyunov, Prof | Contact | 007(495)952-73-77 | arut@ossn.ru |
| Name | Affiliation | Role |
|---|---|---|
| Grigory P Arutyunov, Prof | Russian Society for Heart Failure | Principal Investigator |
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| Drug |
|
| 3 months |
| Albuminuria | Appearance of albuminuria of any stage or increasing of albuminuria level in case of existing albuminuria at the baseline. (measured by dipstick) | 3 months |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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