Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

NCT02630355 | Terminated Phase 2

• 1 other identifier: R-15-091
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialysis; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (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

  4 weeks

Secondary Outcomes (4)

• 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

Study Arms (4)

Control

SHAM COMPARATOR

Inflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation

Other: Remote Ischaemic Preconditioning

Low Intensity

ACTIVE COMPARATOR

Inflation of blood pressure cuff in lower limb to 200mmHg for two cycles of 5 minute inflation and then deflation.

Other: Remote Ischaemic Preconditioning

Standard Intensity

ACTIVE COMPARATOR

Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and then deflation.

Other: Remote Ischaemic Preconditioning

High Intensity

ACTIVE COMPARATOR

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

Interventions

Remote Ischaemic Preconditioning OTHER

Inflation of blood pressure cuff in lower limb

Control; High Intensity; Low Intensity; Standard Intensity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• Academic Medical Organization of Southwestern Ontario: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share