Please select the eligibility criteria that correspond to the clinical trial below.
Title: Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
Brief Summary: The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.


Options:
A: Inclusion Criteria:

* Individual is more than 18 and less than 75 years old at time of randomization
* Essential hypertension diagnosed during a complete work-up within the past 2 years
* Office blood pressure ≥140 and/or 90 mmHg despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, including a diuretic
* 2 functional kidneys sizing ≥ 90 mm; eGFR ≥ 40 mL/min/1.73m² (MDRD formula)
* Suitable renal anatomy compatible with the endovascular denervation procedure
* Signed Informed consent
* Confirmed resistant hypertension defined by diurnal ambulatory blood pressure measurement ≥ 135 and/or 85 mmHg after 4 week standardized triple antihypertensive treatment

Exclusion Criteria:

* Patients with an estimated glomerular filtration rate (eGFR) of less than 40 mL/min/1.73 m2
* Patients with secondary hypertension
* Kaliemia ≥ 6mmol/L
* Patient with single functioning kidney
* Patient with contrast media allergy
* Patient with any implantable device incompatible with radiofrequency energy delivery
* Patient with contra-indication to the anti-hypertensive standardized medication regimen
* Patient with transient or fixed cerebral ischemia within 3 months before inclusion
* Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
* Patient with type 1 diabetes mellitus
* Patient with malignancy within the 5 past years
* Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm
B: Inclusion Criteria:

* treatment resistant hypertension
* male of female aged over 18 years
* written informed consent
* agreement to attend all study visits as planned in the protocol

Exclusion Criteria:

* chronic kidney disease 3 - 5
* any contradictions for MRI
* claustrophobia
* strabismus
* severe ocular diseases
* history of epilepsia
C: Inclusion Criteria:

* Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.

Exclusion Criteria:

* Pregnancy
* Non compliance
* Heart Failure (NYHA 3-4)
* LV ejection fraction \< 50 %
* Renal insufficiency (eGFR\<30)
* Unstable coronary heart disease
* Coronary intervention within 6 months
* Myocardial infarction within 6 months
* Claudication
* Orthostatic syncope within 6 months
* Secondary Hypertension
* Permanent atrial fibrillation
* Significant Heart Valve Disease
* Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
* Second and third degree heart block
* Macroscopic haematuria
* Proximal significant coronary stenosis
* Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)
D: TRIO and SOLO Inclusion Criteria:

* Appropriately signed and dated informed consent
* Age ≥18 and ≤75 years at time of consent
* Documented history of essential hypertension
* SOLO Cohort only: Either an average seated office BP \< 180/110 mmHg at screening visit while on a stable regimen of 1 or 2 antihypertensive medications for at least 4 weeks prior to consent or an average seated office BP ≥ 140/90 mmHg \<180/110 mmHg despite lifestyle measures on no antihypertensive medications
* TRIO Cohort only: Average seated office BP ≥ 140/90 mmHg at screening visit while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent
* Documented daytime ABP ≥ 135/85 mmHg and \< 170/105 mmHg after 4-week washout/run-in period (SOLO cohort) or after 4-week stabilization period (TRIO cohort)
* Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in patients without a recent (≤1 year) renal imaging)
* Able and willing to comply with all study procedures

Solo Exclusion Criteria:

* Renal artery anatomy on either side, ineligible for treatment including:

  * Main renal artery diameter \< 4 mm and \> 8 mm
  * Main renal artery length \< 25 mm
  * A single functioning kidney
  * Presence of abnormal kidney (or secreting adrenal) tumors
  * Renal artery with aneurysm
  * Pre-existing renal stent or history of renal artery angioplasty
  * Prior renal denervation procedure
  * Fibromuscular disease of the renal arteries
  * Presence of renal artery stenosis of any origin ≥ 30%
  * Accessory arteries with diameter ≥ 2mm \<4 mm and \> 8 mm\*
* Evidence of active infection within 7 days of procedure
* Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
* Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
* Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis
* eGFR of \<40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
* Brachial circumference ≥ 42 cm
* Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident)
* Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV)
* Documented confirmed episode(s) of stable or unstable angina
* Documented repeat (\>1) hospitalization for hypertensive crisis within the prior 12 months
* Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
* Documented history of persistent or permanent atrial tachyarrhythmia
* Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
* Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Primary pulmonary hypertension
* Documented contraindication or allergy to contrast medium not amenable to treatment
* Limited life expectancy of \< 1 year at the discretion of the Investigator
* Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers)
* Pregnant, nursing or planning to become pregnant (negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

TRIO Exclusion Criteria

* Renal artery anatomy on either side, ineligible for treatment including:

  * Main renal artery diameter \< 3.5 mm and \> 8 mm
  * Main renal artery length \< 20 mm
  * A single functioning kidney
  * Presence of abnormal kidney tumors
  * Renal artery with aneurysm
  * Pre-existing renal stent or history of renal artery angioplasty
  * Pre-existing aortic stent or history of aortic aneurysm
  * Prior renal denervation procedure
  * Fibromuscular disease of the renal arteries
  * Presence of renal artery stenosis of any origin ≥ 30%
  * Accessory arteries with diameter ≥2 mm \<3.5 mm and \> 8 mm\*
* Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
* Evidence of active infection within 7 days of procedure
* Secondary hypertension not including sleep apnea (documented through clinical work up within the 12 months prior to consent- see protocol body for details)
* Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
* Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
* eGFR of \<40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
* Brachial circumference ≥ 42 cm
* Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 3 months prior to consent
* Any history of severe cardiovascular event (e.g. myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent
* Documented repeat (\>1) hospitalization for hypertensive crisis within the prior 3 months
* Documented confirmed episode(s) of unstable angina within 3 months prior to consent
* Documented intolerance or contraindication for any of the antihypertensive drugs prescribed as a requirement of the study protocol
* Prescribed to any standard anti-hypertensive CV medication (other than beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
* Documented history of persistent or permanent atrial tachyarrhythmia
* Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
* Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Primary pulmonary hypertension
* Documented contraindication or allergy to contrast medium not amenable to treatment
* Limited life expectancy of \< 1 year at the discretion of the Investigator
* Night shift workers
* Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
* Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential)
* Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

Answer: C