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

Phase 4

• Conditions: Kidney Failure Chronic; Cardiovascular Diseases
• Interventions: Device: Hemocontrol

• Registration Number: NCT01515878
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Study Start: 2012-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-04
• Last Update Posted: 2012-07-06
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 396

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dialysis with BVT	Hemocontrol	Dialysis using the BVT monitor biofeedback called Hemocontrol

Primary Outcome Measures

Name	Time	Method
Cardiovascular events	36 months	The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events

Secondary Outcome Measures

Name	Time	Method
Dry weight management	36 months	Optional when available at site: Hydration status estimated by Cardiothoracic index or BNP or BIA at baseline and each 12 months
Cardiovascular morbidity	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.
Blood pressure control	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:
Quality of life and dialysis tolerance evaluated with questionnaire.	36 months	Questions of the KDQOL36 questionnaire

Trial Locations

Locations (3)

Health Regional hospital; 🇨🇦 Calgary, Canada

Hopital Tenon, APHP; 🇫🇷 Paris, France

Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy