Clinical trial NCT01515878: Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS
Official title: Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Failure Chronic
Cardiovascular Diseases
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 396
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular events
timeFrame: 36 months
Secondary outcomes:
measure: Cardiovascular morbidity
timeFrame: 36 months
measure: Blood pressure control
timeFrame: 36 months
measure: Quality of life and dialysis tolerance evaluated with questionnaire.
timeFrame: 36 months
measure: Dry weight management
timeFrame: 36 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Health Regional hospital
city: Paris
country: France
facility: Hopital Tenon, APHP
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: Calgary hospital, Canada
name: Jennifer Mac Rae, MD
role: STUDY_CHAIR
affiliation: APHP Tenon, Paris France
name: Hafedh Fessi, MD
role: STUDY_CHAIR
affiliation: Majorca hospital, Spain
name: Juan Buades, MD
role: STUDY_CHAIR
affiliation: AOSP, Bologna Italy
name: Helena Mancini, MD
role: STUDY_CHAIR
affiliation: AOSP, Bologna Italy
name: Antonio Santoro, Pf
role: STUDY_CHAIR
References: