Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02630355
• Other study ID #: R-15-091
• Status: Terminated
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2020
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hemodialysis

Intervention

Other:
• Remote Ischaemic Preconditioning
Inflation of blood pressure cuff in lower limb

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Academic Medical Organization of Southwestern Ontario

Outcome

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