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

January 19, 2012
July 4, 2012
February 2012
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01515878 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS
Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Kidney Failure Chronic
  • Cardiovascular Diseases
Device: Hemocontrol
Blood Volume Tracking system using biofeedback
  • Experimental: Dialysis with BVT
    Dialysis using the BVT monitor biofeedback called Hemocontrol
    Intervention: Device: Hemocontrol
  • No Intervention: Conventional dialysis
    Conventional dialysis without blood volume tracking or similar therapies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
396
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Antonio Santoro, Pf +39 051 6362 430 antonio.santoro@aosp.bo.it
Contact: Helena Mancini, MD elena.mancini@aosp.bo.it
Canada,   France,   Italy
 
NCT01515878
2019
Yes
Antonio Santoro, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Not Provided
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
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP