Renal FailureTnT-HDNCT02111733
Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?
A study testing Hs-TNT dosage in people with Renal Failure, run by Université de Sherbrooke at 2 sites in Canada.
Trial summary
Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal failure patient at Sherbrooke University Hospital Center as determined by serial measurements. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Hs-TNT dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2013to 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 50 years, no symptoms, over 1 months of hemodialysis
Who cannot join
- 1 or more in the last month; Acute coronary syndrome, Heart failure decompensated, Myo or Pericarditis, Pulmonary embolism, Sepsis/shock, Stroke or transient ischemic attack, Malignant high blood pressure, Arrythmia, electrical cardio-version, major trauma, significant burnings (>25%), Chemotherapy, Cardiovascular surgery, percutaneous angio-intervention,
- Chronic systemic disease (sarcoidosis, amyloidosis, LED, Etc.)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
University of Sherbrooke
Sherbrooke, Quebec
About this study
Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal failure patient at Sherbrooke University Hospital Center as determined by serial measurements. Verification of potential effects of these levels and their variation as predictors of cardiovascular outcomes and events at 6 and 12 months.
Read the detailed description
Recruiting of hemodialysis patients of the nephrology renal supplementation clinics at Sherbrooke University Hospital Center to measure three blood level of high-sensibility troponins before and after standard dialysis. Verification on the variation of these levels after dialysis. Follow-up at 6 and 12 months of the patient for Cardiovascular events and death and verification of a possible predictive value of troponin blood levels for these events.
- Conditions
- Renal Failure
- Being tested
- Hs-TNT dosage
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hs-TNT dosageOther
Bloodwork before and after hemodialysis for high sensibility troponins T blood level
| Study group | Role | What they receive |
|---|---|---|
| Hs-TnT | Experimental | Hs-TNT dosage Receives: Other: Hs-TNT dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
High sensibility troponins T blood level variation
Verification of high sensibility troponins T blood after classical hemodialysis compared to pre-treatment levels.
Measured: 1 week
Secondary outcomes (1)
Prognostic value of high sensibility troponins T blood level variation
Evaluation of a potential prognosis value of high sensibility troponins T blood levels and its variation after hemodialysis.
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Nguyen, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111733
- Sponsor's protocol ID
- TnT-HD
- Acronym
- TnT-HD
- Status last verified
- Apr 2014
- First submitted
- 10 Dec 2013
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?
- ClinicalTrials.gov ID
- NCT02111733
- Acronym / sponsor ID
- TnT-HD / TnT-HD
- Conditions
- Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Apr 2014 (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.
Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal failure patient at Sherbrooke University Hospital Center as determined by serial measurements. Verification of potential effects of these levels and their variation as predictors of cardiovascular outcomes and events at 6 and 12 months.
Detailed description
Recruiting of hemodialysis patients of the nephrology renal supplementation clinics at Sherbrooke University Hospital Center to measure three blood level of high-sensibility troponins before and after standard dialysis. Verification on the variation of these levels after dialysis. Follow-up at 6 and 12 months of the patient for Cardiovascular events and death and verification of a possible predictive value of troponin blood levels for these events.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hs-TnT | Experimental | Other: Hs-TNT dosageHs-TNT dosage |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over 50 years, no symptoms, over 1 months of hemodialysis
Key exclusion criteria (2 listed)
- 1 or more in the last month; Acute coronary syndrome, Heart failure decompensated, Myo or Pericarditis, Pulmonary embolism, Sepsis/shock, Stroke or transient ischemic attack, Malignant high blood pressure, Arrythmia, electrical cardio-version, major trauma, significant burnings (>25%), Chemotherapy, Cardiovascular surgery, percutaneous angio-intervention,
- Chronic systemic disease (sarcoidosis, amyloidosis, LED, Etc.)
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 |
|---|---|---|
| Hs-TNT dosageBloodwork before and after hemodialysis for high sensibility troponins T blood level | Other | Hs-TnT |
Primary outcome
High sensibility troponins T blood level variation
Time frame: 1 week
Verification of high sensibility troponins T blood after classical hemodialysis compared to pre-treatment levels.
1 secondary outcome
Prognostic value of high sensibility troponins T blood level variation
Time frame: at 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
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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.
Michel Nguyen, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hs-TNT dosage in people with Renal Failure, run by Université de Sherbrooke at 2 sites in Canada.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
High sensibility troponins T blood level variation (time frame: 1 week). 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 11 Apr 2014.