Cardiovascular Diseases, Kidney Failure Chronic
Conditions
Brief summary
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
Interventions
DEVICEHemocontrol
Blood Volume Tracking system using biofeedback
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age more than 65 years old 2. 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 3. On a three times per week hemodialysis schedule 4. Time on hemodialysis less than 6 months 5. Able to measure their blood pressure at home (by themselves or with the aid of the care giver) 6. Signed informed consent
Exclusion criteria
1. Active neoplastic disease 2. Mental illness 3. Pregnancy 4. Single needle treatment 5. Inability, as judged by the investigator, to follow or understand the protocol instructions 6. Blood flow rate less than 200 mL/min 7. 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 8. Patients with a life expectancy shorter than 6 months 9. Patients in a list for transplant within the next 6 months 10. Predialysis Hemoglobin level greater than 13.5 g/dl 11. History of major cardiovascular events during run in period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular events | 36 months | The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular morbidity | 36 months | * 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. |
| Blood pressure control | 36 months | 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: |
| Quality of life and dialysis tolerance evaluated with questionnaire. | 36 months | Questions of the KDQOL36 questionnaire |
| Dry weight management | 36 months | Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months |
Countries
Canada, France, Italy
Contacts
Primary ContactAntonio Santoro, Pf
Backup ContactHelena Mancini, MD
Outcome results
None listed