Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

Western University, Canada

Status and phase: Terminated; Phase 2

Conditions: Hemodialysis; Cardiovascular Diseases

Treatments: Other: Remote Ischaemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02630355

R-15-091

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Control

Sham Comparator group

Description:

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

Treatment:

Other: Remote Ischaemic Preconditioning

Low Intensity

Active Comparator group

Description:

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

Treatment:

Other: Remote Ischaemic Preconditioning

Standard Intensity

Active Comparator group

Description:

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

Treatment:

Other: Remote Ischaemic Preconditioning

High Intensity

Active Comparator group

Description:

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.

Treatment:

Other: Remote Ischaemic Preconditioning