Status:
UNKNOWN
Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Kidney Failure Chronic
Cardiovascular Diseases
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT01515878
Start Date
February 1 2012
End Date
March 1 2015
Last Update
July 6 2012
Active Locations (3)
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1
Health Regional hospital
Calgary, Canada
2
Hopital Tenon, APHP
Paris, France, 75970
3
Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138