Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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 autoRICĀ® Device or identical sham autoRICĀ® Device.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRIC Treatment | Experimental | An autoRICĀ® 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 Comparator | An autoRICĀ® 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active autoRICĀ® (CRIC Treatment) | Device | The active autoRICĀ® 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of antihypertensive medications | Reduction in number of medications required for treating hypertension | Baseline and 28 days |
| Central aortic systolic pressure | Central aortic systolic pressure (measured by assessing the arterial waveform after 28 days of CRIC or sham control therapy). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Choo, MBBS | Contact | 65 63214426 | jason.choo@singhealth.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Jason Choo, MBBS | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Recruiting | Singapore | 169608 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18456674 | Result | 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. | |
| 23525419 | Result | Luca 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D011507 | Proteinuria |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Control autoRICĀ® (Sham Control) | Device | The Sham Control autoRICĀ® Device is visually identical to the active autoRICĀ® 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. |
|
| Baseline and 28 days |
| Arterial pulse waveform | The arterial pulse waveform (measured after 28 days of CRIC or sham control therapy). | Baseline and 28 days |
| LV systolic and diastolic function | Change in LV systolic and diastolic function assessed by echocardiography from baseline following 28 days of CRIC or sham control therapy (subset of 20 patients). | Baseline and 28 days |
| LV wall thickness | Change in LV wall thickness assessed by echocardiography from baseline following 28 days of CRIC or sham control therapy (subset of 20 patients). | Baseline and 28 days |
| Spot Urine Protein-Creatinine Ratio | Change in Proteinuria assessed by Spot Urine Protein-Creatinine Ratio from baseline after 28 days of CRIC or sham control therapy. | Baseline and 28 days |
| Serum creatinine and eGFR | Change in Renal function (assessed by serum creatinine and eGFR from baseline to after 28 days of CRIC or sham control therapy). | Baseline and 28 days |
| Blood biomarkers for CKD and inflammation | CRP, IL-6, PAI-1, sCD40 ligand, and TNF-alpha will be measured for CKD and inflammation following 28 days of CRIC or sham control therapy. | Baseline and 28 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |