Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
This trial is active, not recruiting.
|Conditions||end-stage renal disease, hypertension|
|Sponsor||Baker IDI Heart and Diabetes Institute|
|Start date||January 2014|
|End date||December 2016|
|Trial size||100 participants|
|Trial identifier||NCT02021019, 1052470, 527/13|
Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Renal denervation using a catheter-based Radio-frequency approach
Blood Pressure change
time frame: 6 months
Male or female participants from 18 years up to 85 years old.
Inclusion Criteria: - end stage renal disease - hypertension (BP≥140/90mmHg) Exclusion Criteria: - Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist. - Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
|Official title||Renal Denervation to Improve Outcomes in Patients With End-stage Renal|
|Principal investigator||Markus P Schlaich, MD|
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