Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value? (TnT-HD)

April 8, 2014 updated by: Université de Sherbrooke
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

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

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
      • Sherbrooke, Quebec, Canada
        • University of Sherbrooke

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

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 50 years, no symptoms, over 1 months of hemodialysis

Exclusion Criteria:

  • 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.)

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hs-TnT
Hs-TNT dosage
Other: Hs-TNT dosage
Bloodwork before and after hemodialysis for high sensibility troponins T blood level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of high sensibility troponins T blood level variation
Time Frame: at 6 and 12 months
Evaluation of a potential prognosis value of high sensibility troponins T blood levels and its variation after hemodialysis.
at 6 and 12 months

Collaborators and Investigators

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

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Michel Nguyen, MD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

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

June 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TnT-HD

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.

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