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

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

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Kidney Failure Chronic
• Intervention / Treatment: Device: Hemocontrol

• Study Type: Interventional
• Enrollment (Anticipated): 396
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada
    • Not yet recruiting
    • Health Regional hospital
    • Contact: Jennifer Mac Rae, MD; Email: jennifer.macrae@calgaryhealthregion.ca
    • Principal Investigator: Jennifer Mac Rae, MD
• France
  • Paris, France, 75970
    • Active, not recruiting
    • Hôpital Tenon, APHP
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Antonio Santoro, Pf; Phone Number: +39 051 63 62 430; Email: antonio.santoro@aosp.bo.it
    • Contact: Elena Mancini, MD; Email: elena.mancini@aosp.bo.it
    • Principal Investigator: Antonio Santoro, Pf
    • Sub-Investigator: Elena Mancini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular events	The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 months
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:	36 months
Quality of life and dialysis tolerance evaluated with questionnaire.	Questions of the KDQOL36 questionnaire	36 months
Dry weight management	Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months	36 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• 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

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 23, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Estimate): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 4, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 2019 (Chief Medical Office (CMO) Alberta Health Services)