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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Information provided by (Responsible Party):
Antonio Santoro, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01515878
First received: January 19, 2012
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Kidney Failure Chronic
Cardiovascular Diseases
Device: Hemocontrol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Cardiovascular events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events


Secondary Outcome Measures:
  • Cardiovascular morbidity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    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. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Questions of the KDQOL36 questionnaire

  • Dry weight management [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months


Estimated Enrollment: 396
Study Start Date: February 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515878

Contacts
Contact: Antonio Santoro, Pf +39 051 6362 430 antonio.santoro@aosp.bo.it
Contact: Helena Mancini, MD elena.mancini@aosp.bo.it

Locations
Canada
Health Regional hospital Not yet recruiting
Calgary, Canada
Contact: Jennifer Mac Rae, MD       jennifer.macrae@calgaryhealthregion.ca   
Principal Investigator: Jennifer Mac Rae, MD         
France
Hopital Tenon, APHP Active, not recruiting
Paris, France, 75970
Italy
Azienda Ospedaliero-Universitaria di Bologna Recruiting
Bologna, Italy, 40138
Contact: Antonio Santoro, Pf    +39 051 63 62 430    antonio.santoro@aosp.bo.it   
Contact: Elena Mancini, MD       elena.mancini@aosp.bo.it   
Principal Investigator: Antonio Santoro, Pf         
Sub-Investigator: Elena Mancini, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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
  More Information

No publications provided

Responsible Party: Antonio Santoro, Professor, MD, Chief of Nephrology, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01515878     History of Changes
Other Study ID Numbers: 2019
Study First Received: January 19, 2012
Last Updated: July 4, 2012
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 28, 2014