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NCT03465917 · ClinicalTrials.gov registry record · Early Phase 1
Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation
A Early Phase 1 study of Hypertension, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03465917 is a Early Phase 1 study of Hypertension that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 5 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03465917, a Early Phase 1 study of Hypertension, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
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 t
Conditions Studied
Interventions
- COMBINATION_PRODUCT Renal Denervation
Study Locations (1)
Texas
- The Institute for Exercise and Environmental Medicine - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2019-11-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03465917
The ClinicalTrials.gov registry entry for NCT03465917 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Renal Denervation is the first listed.
NCT03465917 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03465917 about?
NCT03465917 is a clinical study titled "Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation". 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...
What is the current status of trial NCT03465917?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2018-03-01. Estimated completion is 2019-11-12.
What conditions does trial NCT03465917 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT03465917?
The interventions under investigation include: Renal Denervation (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03465917?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03465917 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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