HemodialysisPhase 2NCT02630355
Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury
A Phase 2 study testing Remote Ischaemic Preconditioning in people with Hemodialysis and Cardiovascular Diseases, run by Western University, Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Cardiovascular Diseases
- What is being tested?
- Remote Ischaemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
- Male and female, age≥16 years old.
Who cannot join
- Not meeting inclusion criteria
- 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
About this study
Official title: Randomized Controlled Trial of Remote Ischaemic Preconditioning to Protect Against Dialysis Induced Cardiac Injury in Haemodialysis: Low Vs. High Intensity
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
- Being tested
- Remote Ischaemic Preconditioning
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischaemic PreconditioningOther
Inflation of blood pressure cuff in lower limb
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Inflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation Receives: 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. Receives: 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. Receives: 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. Receives: Other: Remote Ischaemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (4)
Number of segments undergoing >30% reduction in longitudinal strain at intervention, week 1, week 2 and week 3 visits
Measured: up to 3 weeks
Difference between pre and peak global longitudinal strain at intervention, week 1, week 2 and week 3 visits
Measured: up to 3 weeks
Change in pre-dialysis global longitudinal strain between baseline and final study visit
Measured: between 1 and 4 weeks
Change in Troponin-T, Plasma IL-6 and N-Type proBNP at intervention, first follow-up and final visit
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: The study was terminated prematurely after ad-interim analysis for the primary outcome.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Responsible party
- Principal investigator, Christopher McIntyre, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630355
- Sponsor's protocol ID
- R-15-091
- Status last verified
- Oct 2020
- First submitted
- 8 Dec 2015
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Remote Ischaemic Preconditioning to Protect Against Dialysis Induced Cardiac Injury in Haemodialysis: Low Vs. High Intensity
- ClinicalTrials.gov ID
- NCT02630355
- Acronym / sponsor ID
- R-15-091
- Conditions
- Hemodialysis, Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely after ad-interim analysis for the primary outcome.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Remote Ischaemic PreconditioningInflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation |
| Low Intensity | Active comparator | Other: Remote Ischaemic PreconditioningInflation of blood pressure cuff in lower limb to 200mmHg for two cycles of 5 minute inflation and then deflation. |
| Standard Intensity | Active comparator | Other: Remote Ischaemic PreconditioningInflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and then deflation. |
| High Intensity | Active comparator | Other: Remote Ischaemic PreconditioningInflation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
- Male and female, age≥16 years old.
Key exclusion criteria (8 listed)
- Not meeting inclusion criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischaemic PreconditioningInflation of blood pressure cuff in lower limb | Other | Control, High Intensity, Low Intensity, Standard Intensity |
Primary outcome
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
Time frame: 4 weeks
4 secondary outcomes
Number of segments undergoing >30% reduction in longitudinal strain at intervention, week 1, week 2 and week 3 visits
Time frame: up to 3 weeks
Difference between pre and peak global longitudinal strain at intervention, week 1, week 2 and week 3 visits
Time frame: up to 3 weeks
Change in pre-dialysis global longitudinal strain between baseline and final study visit
Time frame: between 1 and 4 weeks
Change in Troponin-T, Plasma IL-6 and N-Type proBNP at intervention, first follow-up and final visit
Time frame: up to 4 weeks
Results and safety
The study was stopped early (reason given: The study was terminated prematurely after ad-interim analysis for the primary outcome.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remote Ischaemic Preconditioning in people with Hemodialysis and Cardiovascular Diseases, run by Western University, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely after ad-interim analysis for the primary outcome.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.