Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

Study Overview
=================
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.

Official Title
-----------------
Randomized Controlled Trial of Remote Ischaemic Preconditioning to Protect Against Dialysis Induced Cardiac Injury in Haemodialysis: Low Vs. High Intensity

Conditions
-----------------
Hemodialysis, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Remote Ischaemic Preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility Male and female, age≥16 years old. Exclusion Criteria: Not meeting inclusion criteria Exposure to haemodialysis for <90 days prior to recruitment Severe heart failure (New York Heart Association grade IV) Cardiac transplant recipients Mental incapacity to consent Declined to participate Taking cyclosporin Taking ATP-sensitive potassium channel opening or blocking drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Inflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation | Other: Remote Ischaemic Preconditioning<br>* Inflation of blood pressure cuff in lower limb<br>|
| Active Comparator: Low Intensity<br>Inflation of blood pressure cuff in lower limb to 200mmHg for two cycles of 5 minute inflation and then deflation. | Other: Remote Ischaemic Preconditioning<br>* Inflation of blood pressure cuff in lower limb<br>|
| Active Comparator: Standard Intensity<br>Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and then deflation. | Other: Remote Ischaemic Preconditioning<br>* Inflation of blood pressure cuff in lower limb<br>|
| Active Comparator: High Intensity<br>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<br>* Inflation of blood pressure cuff in lower limb<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 4 weeks | 

Secondary Outcome Measures

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