Heart FailureNCT02772146
A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure
A study testing CLS UF in people with Heart Failure and Cardio-Renal Syndrome, run by Triomed AB at 1 site in Germany.
Trial summary
A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Cardio-Renal Syndrome
- What is being tested?
- CLS UF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2016to 23 Jan 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient, 18-80 years of age.
- Prevalent PD patients with CHF with cardio-renal syndrome type II, on stable ultrafiltration, for more than two months, treated with PD based UF according to German national guidelines.
- Therapy resistance of pharmacologic therapy: resistant hypervolemia with ascites, pleural fluid and pulmonary edema
- Recurrent hospitalization with cardiac decompensation, ≥ 2 occasions during the last six months
- Isolated failure of the right heart chamber
- Treatment based on night time APD therapy combined with a day time long dwell.
- Obtained written consent to participate in the study.
Who cannot join
- End stage renal disease requiring dialysis.
- Malignant disease.
- On-going infection.
- Diabetes mellitus.
- HIV and/or hepatitis positive.
- Pregnancy.
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- Breastfeeding women.
- Participation in other clinical trials within one month before inclusion.
- Abdominal hernia.
- Cardiac diseases other than left ventricular heart failure, biventricular heart failure or isolated right heart chamber failure, with volume overload.
- Any immune deficiency.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Nephrology, Heidelberg University Hospital
Heidelberg, Heidelberg, 69120
About this study
A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). The patient will be hospitalized for observation during the test day and during the night following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.
- Conditions
- Heart Failure, Cardio-Renal Syndrome
- Being tested
- CLS UF
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLS UFDevice
Also called Carry LifeTM System Ultra Filtration
One single ultrafiltration session of 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Device: CLS UF | Experimental | The purpose of CLS UF is ultrafiltration and drain of excess fluid in patients with congestive heart failure. The function of the device is to extra corporeally recirculate profiled glucose based PD fluid in a system and maintain glucose levels by adding extra glucose, to an adjustable and constant level, in order to maintain a stable ultrafiltration. Receives: Device: CLS UF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrafiltrated volume
Ultrafiltrated volume during a 10 hours study session.
Measured: 10 hours
Secondary outcomes (4)
Any Adverse Event (AE), Serious Adverse Event (SAE), Adverse Device Effect (ADE) or Serious Adverse Device Effect (SADE) occurring during the study session and until the follow-up visit.
Measured: 2-4 weeks
Patient acceptance of the wearable device
Subjective opinion of each patient
Measured: 10 hours
Measured glucose levels in the re-circulated PD fluid
Measured: 10 hours
Patients acceptability of the re-circulation of PD fluid
Any abdominal symptoms of the drain and fill of PD fluid will be recorded.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start11 May 2016
- Primary completion23 Jan 2017
- Study completion23 Jan 2017
Why it stopped: After 2 patients it was concluded that a large change in exclusion criteria and study design was needed to obtain the ojective for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triomed AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Morath, PD Dr. Med, Principal investigator, Division of Nephrology, Heidelberg University Hospital, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772146
- Sponsor's protocol ID
- CIP Version 1D/2015-12-02
- Other IDs
- CIV-14-07-012440, Tmed-002
- Status last verified
- Feb 2017
- First submitted
- 9 May 2016
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The Sponsor may choose to publish or present data from this clinical investigation.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT02772146
- Acronym / sponsor ID
- CIP Version 1D/2015-12-02
- Conditions
- Heart Failure, Cardio-Renal Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After 2 patients it was concluded that a large change in exclusion criteria and study design was needed to obtain the ojective for the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Triomed ABIndustry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 23 Jan 2017 (actual)
- First posted
- 13 May 2016 (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.
A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). The patient will be hospitalized for observation during the test day and during the night following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: CLS UF | Experimental | Device: CLS UFThe purpose of CLS UF is ultrafiltration and drain of excess fluid in patients with congestive heart failure. The function of the device is to extra corporeally recirculate profiled glucose based PD fluid in a system and maintain glucose levels by adding extra glucose, to an adjustable and constant level, in order to maintain a stable ultrafiltration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient, 18-80 years of age.
- Prevalent PD patients with CHF with cardio-renal syndrome type II, on stable ultrafiltration, for more than two months, treated with PD based UF according to German national guidelines.
- Treatment based on night time APD therapy combined with a day time long dwell.
- Obtained written consent to participate in the study.
Key exclusion criteria (11 listed)
- End stage renal disease requiring dialysis.
- Malignant disease.
- On-going infection.
- Diabetes mellitus.
- HIV and/or hepatitis positive.
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 |
|---|---|---|
| CLS UFAlso: Carry LifeTM System Ultra FiltrationOne single ultrafiltration session of 10 hours. | Device | Device: CLS UF |
Primary outcome
Ultrafiltrated volume
Time frame: 10 hours
Ultrafiltrated volume during a 10 hours study session.
4 secondary outcomes
Any Adverse Event (AE), Serious Adverse Event (SAE), Adverse Device Effect (ADE) or Serious Adverse Device Effect (SADE) occurring during the study session and until the follow-up visit.
Time frame: 2-4 weeks
Patient acceptance of the wearable device
Time frame: 10 hours
Measured glucose levels in the re-circulated PD fluid
Time frame: 10 hours
Patients acceptability of the re-circulation of PD fluid
Time frame: 10 hours
Results and safety
The study was stopped early (reason given: After 2 patients it was concluded that a large change in exclusion criteria and study design was needed to obtain the ojective for the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: Undecided. The Sponsor may choose to publish or present data from this clinical investigation.
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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.
Christian Morath, PD Dr. Med principal investigator
Division of Nephrology, Heidelberg University Hospital, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLS UF in people with Heart Failure and Cardio-Renal Syndrome, run by Triomed AB 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 7 inclusion and 11 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 14 Mar 2017. 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: After 2 patients it was concluded that a large change in exclusion criteria and study design was needed to obtain the ojective for the study). 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?
Ultrafiltrated volume (time frame: 10 hours). 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 14 Mar 2017.