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

NCT ID: NCT01515878

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-03-31

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

Detailed Description

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Conditions

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Kidney Failure Chronic Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dialysis with BVT

Dialysis using the BVT monitor biofeedback called Hemocontrol

Group Type EXPERIMENTAL

Hemocontrol

Intervention Type DEVICE

Blood Volume Tracking system using biofeedback

Conventional dialysis

Conventional dialysis without blood volume tracking or similar therapies

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hemocontrol

Blood Volume Tracking system using biofeedback

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Antonio Santoro

Professor, MD, Chief of Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Mac Rae, MD

Role: STUDY_CHAIR

Calgary hospital, Canada

Hafedh Fessi, MD

Role: STUDY_CHAIR

APHP Tenon, Paris France

Juan Buades, MD

Role: STUDY_CHAIR

Majorca hospital, Spain

Helena Mancini, MD

Role: STUDY_CHAIR

AOSP, Bologna Italy

Antonio Santoro, Pf

Role: STUDY_CHAIR

AOSP, Bologna Italy

Locations

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Health Regional hospital

Calgary, , Canada

Site Status NOT_YET_RECRUITING

Hopital Tenon, APHP

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Canada France Italy

Central Contacts

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Antonio Santoro, Pf

Role: CONTACT

Phone: +39 051 6362 430

Email: [email protected]

Helena Mancini, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jennifer Mac Rae, MD

Role: primary

Antonio Santoro, Pf

Role: primary

Elena Mancini, MD

Role: backup

Other Identifiers

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2019

Identifier Type: -

Identifier Source: org_study_id