Remote Ischaemic Conditioning on Blood Pressure Control in Chronic Kidney Disease Patients (ERIC-BP-CKD)

Singapore Health Services (SingHealth)

Status: Unknown

Conditions: Hypertension; Chronic Kidney Diseases; Cardiovascular Diseases

Treatments: Device: Active autoRIC® (CRIC Treatment); Device: Sham Control autoRIC® (Sham Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT03236350

SHF/CTG059/2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 2 patient groups

CRIC Treatment

Experimental group

Description:

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

Treatment:

Device: Active autoRIC® (CRIC Treatment)

Sham Control

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Control autoRIC® (Sham Control)