Status:
COMPLETED
Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 treat...
Detailed Description
AIM1: The first aim of the study will be to determine the efficacy of chemical renal denervation in altering renal sympathetic nerve activity. This objective will be assessed by change in urinary cate...
Eligibility Criteria
Inclusion
- 1 Please indicate the inclusion criteria for enrollment: Six patients will participate in this study. Patients who present with uncontrolled hypertension (classified as clinic systolic blood pressure not at target level \>140mmHg) to their primary care provider, emergency room (ER), specialist hypertension clinic or urgent care center will be asked to participate.
- Inclusion criteria include:
- Patient presents with treated or untreated hypertension.
- Adults aged 18-75 years, male or female
- Patient has a clinic systolic blood pressure \>140mmHg (average of 3 measurements), or \>135mmHg in patients with type II diabetes
- Patient has a daytime mean systolic blood pressure of ≥135 and diastolic blood pressure ≥85mHg based on 24 hours ambulatory blood pressure monitoring
- Investigator judges that the subject can be managed safely for up to 12 weeks (4 weeks run-in plus 8 weeks post-treatment) with the use of standard background regimen of losartan/hydrochlorothiazide; patients with true resistant hypertension will be required to maintaining current antihypertensive regime for the duration of the study.
- Exclusion Criteria. Any patient who meets any of the following exclusion criteria will not be eligible for the study.
- Patient has known or suspected secondary hypertension
- Use of systemic drugs that may be used for the treatment of hypertension, for a non-hypertension indication for the trial, (e.g. atrial fibrillation/atrial flutter, heart failure, or calcium channel blocker for heart rate control).
- Renal artery stenosis ≥ 50% diameter stenosis, or aneurysm(s)
- Patients with atrial fibrillation.
- Patient has type 1 diabetes
- Patient has type 2 diabetes and evidence of peripheral neuropathy
- History of previous stenting or balloon angioplasty of the renal arteries.
- Untreated hypothyroid or hypo-parathyroid.
- Orthostatic hypotension defined as \>20 mmHg of systolic blood pressure and/or more than 10 mmHg in diastolic blood pressure fall after standing for 3mins
- Renal artery anatomy as assessed by imaging (CT-angiogram or, MR angiogram or renal angiogram) meeting the following criteria:
- Single renal artery or two renal arteries, if either has a diameter of \< 5 mm or \> 7 mm or a length of \< 11 mm,
- Accessory renal arteries with diameter \> 2.0 mm and \< 5.0 mm,
- Excessive renal artery tortuosity based on Investigator judgment,
- Moderate or severe, and diffuse renal artery calcification, and/or
- Renal anatomic renovascular abnormalities (as assessed by renal imaging) that would increase the risk of renal catheterization.
- Occlusive peripheral vascular disease that would preclude percutaneous access for the procedure.
- Patient is known to have a unilateral non-functioning kidney or unequal renal size (\> 2cm difference in renal length between kidneys).
- Single kidney, kidney tumor, urinary tract obstruction, or other anatomic abnormality. Note: Simple renal cysts are not an exclusion.
- Previous renal denervation.
- History of renal transplantation.
- Estimated eGFR (by the CKD-Epi formula) ≤45 mL/min per 1.73 m2, or on chronic renal replacement therapy. Patients with eGFR of \<60 mL/min per 1.73 m2 will undergo additional renal function monitoring post procedure and/or contrast exsposure.
- Unexplained hypokalemia (i.e. K \< 3.5 mEq/L in patients not on a potassium-wasting diuretic).
- Patient in whom an ABPM device cannot be used due to arm size (\>50 cm arm circumference) or other reasons as identified by the Investigator or study coordinator.
- Patient with severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
- Heart failure greater than asymptomatic, New York Heart Association Functional Classification, class I, stage B heart failure
- Patient with history of myocardial infarction, unstable angina pectoris, or stroke during the 6 months prior to screening
- Known primary or secondary pulmonary hypertension.
- Active infection.
- Patient requiring chronic oxygen support or has severe COPD.
- Patient has known hypersensitivity to contrast agents that cannot be adequately pre-medicated
- A known hypersensitivity to Dehydrated Alcohol Injection.
- Platelet count \< 75,000/microliter and/or known bleeding diathesis or coagulopathy at time of screening.
- Receiving anticoagulant drugs (e.g., warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or low molecular weight heparins), that in the opinion of the investigator, would affect the safety of the trial procedure. Use of antiplatelet drugs such as aspirin and/or thienopyridines (e.g., clopidogrel) are permitted.
- Patient has current problems with substance abuse (e.g. alcohol, illegal drugs, etc.).
- Patient on high dose of steroids or immunosuppressant therapy.
- Patient has a history of myocardial infarction, unstable angina pectoris, or stroke during the 3 months prior to screening.
- Patients with a history of pre-eclampsia
- patients with fibromuscular dysplasia
- patients with history of pyelonephritis within 6 months
- patients with history of recurrent (\> one episode) kidney stones or history of kidney stones within the last year
- Pregnant or nursing or planning to become pregnant during the trial time period.
- Note: If subject is of childbearing potential, as defined in the protocol, agrees to use of contraception.
- Any acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures, or has a life expectancy of \< 12 months.
Exclusion
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03465917
Start Date
March 1 2018
End Date
November 12 2019
Last Update
May 11 2020
Active Locations (1)
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1
The Institute for Exercise and Environmental Medicine
Dallas, Texas, United States, 75231