Effect of HCO1100 on Cardiovascular Function (HicoCARD)

March 11, 2025 updated by: Vantive Health LLC

Effect of High Cut-off Membranes on Cardiovascular Function in Patients With End-stage Renal Disease (HICOCARD)

The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular events are the leading cause of the increased mortality rate of chronic dialysis patients. It is believed that increased micro-inflammation plays an important role in the pathophysiological process of cardiovascular disease. High porous dialysis membranes can better eliminate inflammatory mediators as compared to standard dialysis membranes. In this study, the high porous dialysis membrane HCO1100 is investigated for its potential capability to improve the cardiovascular status of chronic dialysis patients.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Dialysis dependent chronic renal failure (CKD 5) in a stable condition
  • Serum albumin at randomisation equal to or above the median of the normal range (pre- dialysis value)

Exclusion Criteria:

  • Diabetes mellitus as the disease underlined end stage renal failure
  • Haemodynamic instability that precludes unsupported dialysis
  • planned surgical interventions <= 4 months at time of inclusion
  • known allergy against dialysis membranes
  • Significant cardiac disease (atrial fibrillation, myocardial infarction within 6 months; unstable angina pectoris; LV-EF < 30%, clinically significant pericardial disease; cardiac amyloidosis)
  • pulmonary disease with chronic hypoxia
  • Advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and not subject to active or disease specific treatment
  • Clinically significant liver dysfunction (bilirubin > 1.8mg/dl (30µmol/L))
  • Prior fistula surgery on both arms or other operations or paralysis on both arms
  • Known HIV, HCV infection
  • Alcoholism
  • Active uncontrolled infection
  • Pregnancy or lactation
  • Inability to give informed consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dialysis treatment with HCO1100
Device: HCO 1100
Dialysis treatment with HCO1100
Other Names:
  • High cut-off membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)
Time Frame: max 15 weeks
Changes of CHRS (ms/mmHg) and FMD (%) between pre- and post- treatment phase with study product HCO1100 dialyzer and at 6 weeks follow up after termination of HCO1100 dialyzer treatment phase will be assessed.
max 15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly assessment of albumin plasma levels (g/l)
Time Frame: max 15 weeks
Weekly evaluation of albumin plasma levels (g/l) during the study. Patients with albumin plasma levels below 35g/l will terminate study product (HCO1100 dialyzer) treatment phase and switch to study phase with control standard dialyzer treatment and will be further monitored for 6 weeks. Number of patients with decreased albumin levels below 35g/l , Number of patients with requirement for albumin substitution and absolute albumin drop (g/l) will be evaluated.
max 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vantive Health LLC

Collaborators

Baxter Healthcare Corporation
Gambro Dialysatoren GmbH

Investigators

  • Principal Investigator: Juergen Floege, MD, Med.Klinik II, Universitätsklinikum Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimated)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HicoCARD 1481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe