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The study was terminated prematurely after ad-interim analysis for the primary outcome.
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| Name | Class |
|---|---|
| Academic Medical Organization of Southwestern Ontario | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Inflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation |
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| Low Intensity | Active Comparator | Inflation of blood pressure cuff in lower limb to 200mmHg for two cycles of 5 minute inflation and then deflation. |
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| Standard Intensity | Active Comparator | Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and then deflation. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischaemic Preconditioning | Other | Inflation of blood pressure cuff in lower limb |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 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 |