Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

Phase 2

Terminated

• Conditions: Hemodialysis; Cardiovascular Diseases
• Interventions: Other: Remote Ischaemic Preconditioning

• Registration Number: NCT02630355
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-15
• Study Start: 2016-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Intensity	Remote Ischaemic Preconditioning	Inflation of blood pressure cuff in lower limb to 200mmHg for two cycles of 5 minute inflation and then deflation.
Standard Intensity	Remote Ischaemic Preconditioning	Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and then deflation.
Control	Remote Ischaemic Preconditioning	Inflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation
High Intensity	Remote Ischaemic Preconditioning	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Troponin-T, Plasma IL-6 and N-Type proBNP at intervention, first follow-up and final visit	up to 4 weeks
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