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It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialysis with BVT | Experimental | Dialysis using the BVT monitor biofeedback called Hemocontrol |
|
| Conventional dialysis | No Intervention | Conventional dialysis without blood volume tracking or similar therapies |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemocontrol | Device | Blood Volume Tracking system using biofeedback |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular events | The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular morbidity |
| 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Santoro, Pf | Contact | +39 051 6362 430 | antonio.santoro@aosp.bo.it | |
| Helena Mancini, MD | Contact | elena.mancini@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Mac Rae, MD | Calgary hospital, Canada | Study Chair |
| Hafedh Fessi, MD | APHP Tenon, Paris France | Study Chair |
| Juan Buades, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Regional hospital | Not yet recruiting | Calgary | Canada |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Blood pressure control | Blood pressure control:
| 36 months |
| Quality of life and dialysis tolerance evaluated with questionnaire. | Questions of the KDQOL36 questionnaire | 36 months |
| Dry weight management | Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months | 36 months |
| Majorca hospital, Spain |
| Study Chair |
| Helena Mancini, MD | AOSP, Bologna Italy | Study Chair |
| Antonio Santoro, Pf | AOSP, Bologna Italy | Study Chair |
| Hopital Tenon, APHP | Active, not recruiting | Paris | 75970 | France |
| Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
|
| 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 |