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Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

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ClinicalTrials.gov Identifier: NCT02630355
Recruitment Status : Terminated (The study was terminated prematurely after ad-interim analysis for the primary outcome.)
First Posted : December 15, 2015
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Academic Medical Organization of Southwestern Ontario
Information provided by (Responsible Party):
Christopher McIntyre, Western University, Canada

Brief Summary:
This study evaluates the use of remote ischaemic preconditioning for the prevention of dialysis induced cardiac injury. The study uses four arms to test different frequencies of application to ascertain which, if any, is most successful at reducing dialysis induced cardiac injury.

Condition or disease Intervention/treatment Phase
Hemodialysis Cardiovascular Diseases Other: Remote Ischaemic Preconditioning Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Remote Ischaemic Preconditioning to Protect Against Dialysis Induced Cardiac Injury in Haemodialysis: Low Vs. High Intensity
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Sham Comparator: Control
Inflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation
Other: Remote Ischaemic Preconditioning
Inflation of blood pressure cuff in lower limb

Active Comparator: Low Intensity
Inflation of blood pressure cuff in lower limb to 200mmHg for two cycles of 5 minute inflation and then deflation.
Other: Remote Ischaemic Preconditioning
Inflation of blood pressure cuff in lower limb

Active Comparator: Standard Intensity
Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and then deflation.
Other: Remote Ischaemic Preconditioning
Inflation of blood pressure cuff in lower limb

Active Comparator: High Intensity
Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and deflation on weekly basis for four consecutive weeks.
Other: Remote Ischaemic Preconditioning
Inflation of blood pressure cuff in lower limb




Primary Outcome Measures :
  1. The primary outcome will be a reduction in the number of left ventricular segments undergoing a greater than 30% reduction in longitudinal strain as detected by echocardiography at final study visit [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Number of segments undergoing >30% reduction in longitudinal strain at intervention, week 1, week 2 and week 3 visits [ Time Frame: up to 3 weeks ]
  2. Difference between pre and peak global longitudinal strain at intervention, week 1, week 2 and week 3 visits [ Time Frame: up to 3 weeks ]
  3. Change in pre-dialysis global longitudinal strain between baseline and final study visit [ Time Frame: between 1 and 4 weeks ]
  4. Change in Troponin-T, Plasma IL-6 and N-Type proBNP at intervention, first follow-up and final visit [ Time Frame: up to 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
  2. Male and female, age≥16 years old.

Exclusion Criteria:

  1. Not meeting inclusion criteria
  2. Exposure to haemodialysis for <90 days prior to recruitment
  3. Severe heart failure (New York Heart Association grade IV)
  4. Cardiac transplant recipients
  5. Mental incapacity to consent
  6. Declined to participate
  7. Taking cyclosporin
  8. Taking ATP-sensitive potassium channel opening or blocking drugs
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Responsible Party: Christopher McIntyre, Dr., Western University, Canada
ClinicalTrials.gov Identifier: NCT02630355    
Other Study ID Numbers: R-15-091
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiovascular Diseases