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

Cardiovascular Diseases Clinical Trial

— HERACLES  

Official title:

Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01515878
• Other study ID #: 2019
• Status: Recruiting
• Phase: Phase 4
• First received: January 19, 2012
• Last updated: July 4, 2012
• Start date: February 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2012
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Antonio Santoro, Pf
• Phone: +39 051 6362 430
• Email: antonio.santoro[@]aosp.bo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kidney Failure Chronic
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Device:
• Hemocontrol
Blood Volume Tracking system using biofeedback

Locations

Country	Name	City	State
Canada	Health Regional hospital	Calgary
France	Hopital Tenon, APHP	Paris
Italy	Azienda Ospedaliero-Universitaria di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Countries where clinical trial is conducted

Canada,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events	The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events	36 months	Yes
Secondary	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	No
Secondary	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	No
Secondary	Quality of life and dialysis tolerance evaluated with questionnaire.	Questions of the KDQOL36 questionnaire	36 months	No
Secondary	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	No