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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01515878
Recruitment Status : Unknown
Verified July 2012 by Antonio Santoro, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was:  Recruiting
First Posted : January 24, 2012
Last Update Posted : July 6, 2012
Information provided by (Responsible Party):
Antonio Santoro, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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

Condition or disease Intervention/treatment Phase
Kidney Failure Chronic Cardiovascular Diseases Device: Hemocontrol Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS
Study Start Date : February 2012
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Dialysis with BVT
Dialysis using the BVT monitor biofeedback called Hemocontrol
Device: Hemocontrol
Blood Volume Tracking system using biofeedback
No Intervention: Conventional dialysis
Conventional dialysis without blood volume tracking or similar therapies

Primary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 36 months ]
    The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events

Secondary Outcome Measures :
  1. Cardiovascular morbidity [ Time Frame: 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.

  2. Blood pressure control [ Time Frame: 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:

  3. Quality of life and dialysis tolerance evaluated with questionnaire. [ Time Frame: 36 months ]
    Questions of the KDQOL36 questionnaire

  4. Dry weight management [ Time Frame: 36 months ]
    Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01515878

Contact: Antonio Santoro, Pf +39 051 6362 430
Contact: Helena Mancini, MD

Health Regional hospital Not yet recruiting
Calgary, Canada
Contact: Jennifer Mac Rae, MD   
Principal Investigator: Jennifer Mac Rae, MD         
Hopital Tenon, APHP Active, not recruiting
Paris, France, 75970
Azienda Ospedaliero-Universitaria di Bologna Recruiting
Bologna, Italy, 40138
Contact: Antonio Santoro, Pf    +39 051 63 62 430   
Contact: Elena Mancini, MD   
Principal Investigator: Antonio Santoro, Pf         
Sub-Investigator: Elena Mancini, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Study Chair: Jennifer Mac Rae, MD Calgary hospital, Canada
Study Chair: Hafedh Fessi, MD APHP Tenon, Paris France
Study Chair: Juan Buades, MD Majorca hospital, Spain
Study Chair: Helena Mancini, MD AOSP, Bologna Italy
Study Chair: Antonio Santoro, Pf AOSP, Bologna Italy

Responsible Party: Antonio Santoro, Professor, MD, Chief of Nephrology, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi Identifier: NCT01515878     History of Changes
Other Study ID Numbers: 2019
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Cardiovascular Diseases
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic