Cardiovascular DiseaseHicoCARDNCT01363921
Effect of HCO1100 on Cardiovascular Function
A study testing HCO 1100 in people with Cardiovascular Disease and Chronic Kidney Failure, run by Vantive Health LLC at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Chronic Kidney Failure
- What is being tested?
- HCO 1100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease, Chronic Kidney Failure
- Being tested
- HCO 1100
- Keywords
- CKD5, dialysis, high porous membranes, micro-inflammation
- Medical subject headings
- Cardiovascular Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCO 1100Device
Also called High cut-off membrane
Dialysis treatment with HCO1100
| Study group | Role | What they receive |
|---|---|---|
| Dialysis treatment with HCO1100 | Experimental | Not described Receives: Device: HCO 1100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)
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.
Measured: max 15 weeks
Secondary outcomes (1)
Weekly assessment of albumin plasma levels (g/l)
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.
Measured: max 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: insufficient patient recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Juergen Floege, MD, Principal investigator, Med.Klinik II, Universitätsklinikum Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363921
- Sponsor's protocol ID
- HicoCARD 1481
- Acronym
- HicoCARD
- Status last verified
- Mar 2025
- First submitted
- 26 May 2011
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Cut-off Membranes on Cardiovascular Function in Patients With End-stage Renal Disease (HICOCARD)
- ClinicalTrials.gov ID
- NCT01363921
- Acronym / sponsor ID
- HicoCARD / HicoCARD 1481
- Conditions
- Cardiovascular Disease, Chronic Kidney Failure
- Keywords
- CKD5, dialysis, high porous membranes, micro-inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patient recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis treatment with HCO1100 | Experimental | Device: HCO 1100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCO 1100Also: High cut-off membraneDialysis treatment with HCO1100 | Device | Dialysis treatment with HCO1100 |
Primary outcome
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.
1 secondary outcome
Weekly assessment of albumin plasma levels (g/l)
Time frame: max 15 weeks
Results and safety
The study was stopped early (reason given: insufficient patient recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juergen Floege, MD principal investigator
Med.Klinik II, Universitätsklinikum Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCO 1100 in people with Cardiovascular Disease and Chronic Kidney Failure, run by Vantive Health LLC at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient patient recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD) (time frame: max 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.