Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS

Study Overview
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Brief Summary
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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

Official Title
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Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS

Conditions
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Kidney Failure Chronic, Cardiovascular Diseases

Intervention / Treatment
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* Device: Hemocontrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 65 years old Arterial Hypertension: predialysis SBP >140 mmHg and/or DBP >90 mmHg in at least 50% over the previous month dialysis sessions or receiving at least one antihypertensive pharmacological drug including diuretics, disregarded blood pressure value On a three times per week hemodialysis schedule Time on hemodialysis less than 6 months Able to measure their blood pressure at home (by themselves or with the aid of the care giver) Signed informed consent Exclusion Criteria: Active neoplastic disease Mental illness Pregnancy Single needle treatment Inability, as judged by the investigator, to follow or understand the protocol instructions Blood flow rate less than 200 mL/min Patients who at the time of recruitment need clinical indication for special renal replacement therapies and/or on treatment with one of the following modalities: HDF or similar diffusive-convective therapies, treatment time >5h, blood temperature control, isolated UF profiling of Na/UFR Patients with a life expectancy shorter than 6 months Patients in a list for transplant within the next 6 months Predialysis Hemoglobin level greater than 13.5 g/dl History of major cardiovascular events during run in period

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialysis with BVT<br>Dialysis using the BVT monitor biofeedback called Hemocontrol | Device: Hemocontrol<br>* Blood Volume Tracking system using biofeedback<br>|
| No Intervention: Conventional dialysis<br>Conventional dialysis without blood volume tracking or similar therapies | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular morbidity | Number of hospital admissions evaluated as annual hospitalization rate related to: Non fatal myocardial infarction, New-onset angina, Non fatal stroke, Congestive heart failure, Transient ischemic attack, Pulmonary oedema Length of stay during hospitalization; Number of extra dialysis or prolonged dialysis due to fluid overload. | 36 months | 
| Blood pressure control | Blood pressure control: Predialysis blood pressure measurements Home blood pressure self assessment Antihypertensive therapy changes Proportion of patients achieving adequate blood pressure control Intradialytic acute hypotension: | 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 |