Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03465917|
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : May 11, 2020
Hypertension is a major risk factor for heart disease and stroke, two of the leading causes of death in the United States. Hypertension is a common and widespread problem; unfortunately, current treatment strategies fail to adequately control blood pressure in up to 50% of patients either because of failure to take prescribed medications (because of cost, side effects, inconvenience etc.) or lack of therapeutic response. Indeed, it is estimated that 50% of patients stop taking antihypertensive medication within 6-12 months after the initiation of drug therapy.
Despite enthusiasm for a novel approach called renal denercation, presently there are no integrative studies of the antihypertensive effect of renal denervation on the multiple regulatory pathways it may consequentially affect. Experimental evidence from pre-clinical models suggests the effects are due to reducing efferent sympathetic activity and thus lowering blood pressure by altering the renin-angiotensin system. Uncontrolled clinical studies in humans suggest that when effective, this procedure may also lower renal sympathetic nerve activity. However the sympathetic response to monopolar radiofrequency therapy has been highly variable. Moreover, there have been no assessments of procedural efficacy performed in humans. Thus the actual mechanism by which this type of procedure reduces BP in humans is largely unknown, making it extremely difficult to identify the appropriate patients for this invasive procedure.
Recently, chemical renal denervation using ethanol (EtOH), was demonstrated to markedly lower blood pressure in small numbers of patients with resistant hypertension. However the mechanisms by which blood pressure is altered using this novel technique in humans is entirely unknown, and procedural efficacy has also not been assessed. Therefore it is unclear, whether in humans renal sympathetic nerve activity is lowered following renal denervation using this new approach. The Investigators propose to use high resolution physiological testing to determine the effects of chemical renal artery denervation on sympathetic activity.
Therefore the global objective of this physiological study is to provide the first detailed assessment of the integrated mechanistic effects of chemical renal nerve denervation in humans with hypertension that is uncontrolled by conventional treatment (because of lack of adherence or response to therapy).
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Combination Product: Renal Denervation||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||March 6, 2019|
|Actual Study Completion Date :||November 12, 2019|
Experimental: Renal Denervation
Renal denervation using the Peregrine Catheter for extravascular administration of ethanol
Combination Product: Renal Denervation
Bilateral denervation of the renal arteries using extravascular administration of neurolytic alcohol
- Renal sympathetic activity [ Time Frame: Change in renal sympathetic activity at 8 weeks ]18F-Fluorodopamine scanning of the kidney
- Blood pressure [ Time Frame: Change in ambulatory blood pressure 24 hours, 1 week, 8 weeks, 6 months and 12 months after denervation. ]24-hour ambulatory blood pressure
- Muscle sympathetic activity [ Time Frame: Change in Muscle sympathetic nervous system activity 8 weeks, 6 months after renal denervation ]Muscle sympathetic nervous system activity at rest and during autonomic function testing
- Vascular function [ Time Frame: Change in flow mediated dilation 8 weeks, 6 months after renal denervation ]Flow mediated dilation
- Vascular stiffness [ Time Frame: Change in pulswave velocity at 8 weeks, 6 months after renal denervation ]Pulse wave velocity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465917
|United States, Texas|
|The Institute for Exercise and Environmental Medicine|
|Dallas, Texas, United States, 75231|