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

Primary Purpose

Kidney Failure Chronic, Cardiovascular Diseases

Status

Unknown status

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Hemocontrol

About this trial

This is an interventional prevention trial for Kidney Failure Chronic

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Health Regional hospital
Hopital Tenon, APHP
Azienda Ospedaliero-Universitaria di BolognaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dialysis with BVT

Conventional dialysis

Arm Description

Dialysis using the BVT monitor biofeedback called Hemocontrol

Conventional dialysis without blood volume tracking or similar therapies

Outcomes

Primary Outcome Measures

Cardiovascular events

The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events

Secondary Outcome Measures

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.

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:

Quality of life and dialysis tolerance evaluated with questionnaire.

Questions of the KDQOL36 questionnaire

Dry weight management

Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months

Full Information

NCT ID

NCT01515878

First Posted

January 19, 2012

Last Updated

July 4, 2012

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Study Identification

Unique Protocol Identification Number

NCT01515878

Brief Title

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

Acronym

HERACLES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure Chronic, Cardiovascular Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

396 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dialysis with BVT

Arm Type

Experimental

Arm Description

Dialysis using the BVT monitor biofeedback called Hemocontrol

Arm Title

Conventional dialysis

Arm Type

No Intervention

Arm Description

Conventional dialysis without blood volume tracking or similar therapies

Intervention Type

Device

Intervention Name(s)

Hemocontrol

Intervention Description

Blood Volume Tracking system using biofeedback

Primary Outcome Measure Information:

Title

Cardiovascular events

Description

The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Cardiovascular morbidity

Description

Time Frame

36 months

Title

Blood pressure control

Description

Time Frame

36 months

Title

Quality of life and dialysis tolerance evaluated with questionnaire.

Description

Questions of the KDQOL36 questionnaire

Time Frame

36 months

Title

Dry weight management

Description

Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antonio Santoro, Pf

Phone

+39 051 6362 430

antonio.santoro@aosp.bo.it

First Name & Middle Initial & Last Name or Official Title & Degree

Helena Mancini, MD

elena.mancini@aosp.bo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Mac Rae, MD

Organizational Affiliation

Calgary hospital, Canada

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hafedh Fessi, MD

Organizational Affiliation

APHP Tenon, Paris France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Juan Buades, MD

Organizational Affiliation

Majorca hospital, Spain

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Helena Mancini, MD

Organizational Affiliation

AOSP, Bologna Italy

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Antonio Santoro, Pf

Organizational Affiliation

AOSP, Bologna Italy

Official's Role

Study Chair

Facility Information:

Facility Name

Health Regional hospital

City

Calgary

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Mac Rae, MD

jennifer.macrae@calgaryhealthregion.ca

First Name & Middle Initial & Last Name & Degree

Jennifer Mac Rae, MD

Facility Name

Hopital Tenon, APHP

City

Paris

ZIP/Postal Code

75970

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Azienda Ospedaliero-Universitaria di Bologna

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio Santoro, Pf

Phone

+39 051 63 62 430

antonio.santoro@aosp.bo.it

First Name & Middle Initial & Last Name & Degree

Elena Mancini, MD

elena.mancini@aosp.bo.it

First Name & Middle Initial & Last Name & Degree

Antonio Santoro, Pf

First Name & Middle Initial & Last Name & Degree

Elena Mancini, MD

12. IPD Sharing Statement

Learn more about this trial

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

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