Remote Ischaemic Conditioning on Blood Pressure Control in Chronic Kidney Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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Chronic kidney disease (CKD) is one of the leading causes of death and disability in Singapore and worldwide. CKD patients often suffer with inadequately controlled hypertension, the presence of which is associated with cardiovascular complications such as left ventricular (LV) hypertrophy, cardiac failure, and stroke. As such, novel treatments are required to improve blood pressure control in order to improve health outcomes in CKD patients.

Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the kidney and microvasculature in experimental and clinical studies, and daily episodes of RIC (termed chronic RIC or CRIC) 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. Whether CRIC can reduce SBP in hypertensive patients with CKD is not known. 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.

In this study, subjects will be randomised in a 1:1 ratio to receive therapy from either the active autoRIC® Device or identical sham autoRIC® Device.

Conditions

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Chronic Kidney Diseases Hypertension Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CRIC Treatment

An autoRIC® Device will be placed on the upper arm daily to complete the preset protocol and will be repeated daily for 28 days.

Group Type EXPERIMENTAL

Active autoRIC® (CRIC Treatment)

Intervention Type DEVICE

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.

Sham Control

An 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.

Group Type SHAM_COMPARATOR

Sham Control autoRIC® (Sham Control)

Intervention Type DEVICE

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.

Interventions

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Active autoRIC® (CRIC Treatment)

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.

Intervention Type DEVICE

Sham Control autoRIC® (Sham Control)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent
2. Aged 21 years and older
3. CKD (all stages 1-4)
4. On treatment for hypertension and automated office BP (AOBP) ≥ 140mmHg (this will be determined by an automated oscillometric BP device)

Exclusion Criteria

1. Patients with polycystic kidney disease
2. Atrial fibrillation
3. Patients on long-acting sulphonylureas (eg glibenclamide) or nicorandil (as these medications may interfere with the protective effect of CRIC).
4. Patients recruited into another study which may impact on this study.
5. Symptomatic peripheral arterial disease affecting the upper limbs (given nature of upper-limb CRIC protocol).
6. Renal transplant / Dialysis patients
7. Pregnant patients
8. Patients on any anti-coagulant medications (e.g. Warfarin)
9. For echo sub-study only: Prior myocardial infarction, BMI \> 30kg/m2, known severe acrdiac valve disease, known severely impaired LVEF \<35%

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No