Hypertension Clinical Trial
— ERIC-BP-CKDOfficial title:
The Effect of Remote Ischaemic Conditioning on Blood Pressure Control in Patients With Chronic Kidney Disease - the ERIC-BP-CKD Trial
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.
Status | Recruiting |
Enrollment | 85 |
Est. completion date | June 30, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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% |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital | Duke-NUS Graduate Medical School |
Singapore,
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. Review. — View Citation
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.112.000 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of antihypertensive medications | Reduction in number of medications required for treating hypertension | Baseline and 28 days | |
Secondary | Central aortic systolic pressure | Central aortic systolic pressure (measured by assessing the arterial waveform after 28 days of CRIC or sham control therapy). | Baseline and 28 days | |
Secondary | Arterial pulse waveform | The arterial pulse waveform (measured after 28 days of CRIC or sham control therapy). | Baseline and 28 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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