Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

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

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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Hemodialysis
• Intervention / Treatment: Other: Remote Ischaemic Preconditioning

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Academic Medical Organization of Southwestern Ontario

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: R-15-091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO