Remote Ischaemic Conditioning on Blood Pressure Control in Chronic Kidney Disease Patients
ERIC-BP-CKD
The Effect of Remote Ischaemic Conditioning on Blood Pressure Control in Patients With Chronic Kidney Disease - the ERIC-BP-CKD Trial
1 other identifier
interventional
85
1 country
1
Brief Summary
Chronic kidney disease (CKD) is one of the leading causes of death and disability in Singapore and worldwide. Hypertension is commonly inadequately controlled in patients with CKD and this is associated with CKD progression and cardiovascular complications. Daily episodes of Remote ischaemic conditioning (termed chronic RIC or CRIC) using transient limb ischaemia/reperfusion applied for 1 to 12 months have been shown to lower systemic blood pressure (SBP), prevent stroke and reduce post-myocardial infarction left ventricular (LV) remodelling in experimental and clinical studies. In the ERIC-BP-CKD feasibility and efficacy study, we hypothesise that CRIC administered for 28 days will lower systemic blood pressure and improve blood pressure control in patients with CKD and hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
November 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedSeptember 23, 2019
September 1, 2019
2.3 years
July 25, 2017
September 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic blood pressure
Difference in change in systolic blood pressure (measured by automated office blood pressure recording) from baseline to after 28 days between CRIC versus sham control therapy.
Baseline and 28 days
Secondary Outcomes (8)
Number of antihypertensive medications
Baseline and 28 days
Central aortic systolic pressure
Baseline and 28 days
Arterial pulse waveform
Baseline and 28 days
LV systolic and diastolic function
Baseline and 28 days
LV wall thickness
Baseline and 28 days
- +3 more secondary outcomes
Study Arms (2)
CRIC Treatment
EXPERIMENTALAn autoRIC® Device will be placed on the upper arm daily to complete the preset protocol and will be repeated daily for 28 days.
Sham Control
SHAM COMPARATORAn autoRIC® Device visually identical to that used in the CRIC protocol will be placed on the upper arm daily to complete the preset protocol and will be repeated daily for 28 days.
Interventions
The active autoRIC® Device is programmed to go through a preset protocol of inflation and deflation cycles every session. The sessions will be repeated daily for 28 days.
The Sham Control autoRIC® Device is visually identical to the active autoRIC® Device but the simulated protocol applied comprises of vibrations of the device but no inflation of the cuff every session. The sham device provides the same sound and vibration as that of the pump inflating and the same LED indicators on the Active Unit. The sessions will be repeated daily for 28 days.
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Aged 21 years and older
- CKD (all stages 1-4)
- On treatment for hypertension and automated office BP (AOBP) ≥ 140mmHg (this will be determined by an automated oscillometric BP device)
You may not qualify if:
- Patients with polycystic kidney disease
- Atrial fibrillation
- Patients on long-acting sulphonylureas (eg glibenclamide) or nicorandil (as these medications may interfere with the protective effect of CRIC).
- Patients recruited into another study which may impact on this study.
- Symptomatic peripheral arterial disease affecting the upper limbs (given nature of upper-limb CRIC protocol).
- Renal transplant / Dialysis patients
- Pregnant patients
- Patients on any anti-coagulant medications (e.g. Warfarin)
- For echo sub-study only: Prior myocardial infarction, BMI \> 30kg/m2, known severe acrdiac valve disease, known severely impaired LVEF \<35%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Singapore General Hospitallead
- Duke-NUS Graduate Medical Schoolcollaborator
Study Sites (1)
Singapore General Hospital
Singapore, 169608, Singapore
Related Publications (2)
Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
PMID: 18456674RESULTLuca MC, Liuni A, McLaughlin K, Gori T, Parker JD. Daily ischemic preconditioning provides sustained protection from ischemia-reperfusion induced endothelial dysfunction: a human study. J Am Heart Assoc. 2013 Feb 22;2(1):e000075. doi: 10.1161/JAHA.112.000075.
PMID: 23525419RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Choo, MBBS
Singapore General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2017
First Posted
August 1, 2017
Study Start
November 28, 2017
Primary Completion
March 31, 2020
Study Completion
June 30, 2020
Last Updated
September 23, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share