Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?

Renal Failure Clinical Trial

— TnT-HD  

Official title:

Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111733
• Other study ID #: TnT-HD
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: April 8, 2014
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. Verification of potential effects of these levels and their variation as predictors of cardiovascular outcomes and events at 6 and 12 months.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Failure

Intervention

Other:
• Hs-TNT dosage
Bloodwork before and after hemodialysis for high sensibility troponins T blood level

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	University of Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High sensibility troponins T blood level variation	Verification of high sensibility troponins T blood after classical hemodialysis compared to pre-treatment levels.	1 week	No
Secondary	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.	at 6 and 12 months	No