Please select the eligibility criteria that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Resistant Hypertension
Brief Summary: The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.


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:

* Inclusion Criteria
* Age ≥ 18 years of age
* History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure
* History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).
* Renal vasculature is accessible as determined by intra-procedural renal angiography.
* Ability to understand the requirements of the study
* Willingness to adhere to study restrictions, comply with all post-procedural follow-up requirements and to sign informed consent

Exclusion Criteria

* Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
* Prior left atrial ablation for an atrial arrhythmia (before this index procedure)
* Patients with NYHA class IV congestive heart failure
* Individual has known secondary hypertension
* Individual has renal artery anatomy that is ineligible for treatment including:

  1. Inability to access renal vasculature
  2. Main renal arteries \< 3 mm in diameter or \< 20 mm in length.
  3. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
  4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.
* Individual has an estimated glomerular filtration rate (eGFR) of less than 45mL/min/1.73m2, using the MDRD calculation.
* Individual has a single functioning kidney (either congenitally or iatrogenically).
* Individual is pregnant or nursing.
* Life expectancy \<1 year for any medical condition
C: Inclusion Criteria:

* Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
* Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.
* Individual is willing to discontinue current antihypertensive medications.

Exclusion Criteria:

* Individual lacks appropriate renal artery anatomy.
* Individual has estimated glomerular filtration rate (eGFR) of \<45.
* Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
* Individual has one or more episodes of orthostatic hypotension.
* Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to become pregnant.
* Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
* Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
* Individual works night shifts.
D: Inclusion criteria:

* Women and men are eligible. Women of reproductive age should apply effective contraception.
* Age ranges from 20 years (inclusive) to less than 70 years.
* Patients should have essential hypertension.
* Treatment-resistant hypertension in patients taking a stable drug regimen for at least 4 weeks consisting of 3 or more antihypertensive medications from different classes, including a diuretic.
* Under maximal therapy, office blood pressure should be ≥140/90 mmHg and the 24-h ambulatory blood pressure should be 130 mm Hg systolic or 80 mm Hg diastolic or higher.
* eGFR must be ≥ 60 mL/min/1.73 m2.
* The patients should accept to have adherence checked before randomisation and during supervised follow-up, but both patients and doctors will remain blinded to the results;
* Informed written consent.

Exclusion criteria:

* Suboptimal clinical context, because of recent history or concurrent disease.
* Isolated systolic and diastolic hypertension.
* Body-mass index ≥ 40kg/m2.
* The anatomy of the renal arteries is suboptimal for renal denervation.
* Pregnancy.
* Alcohol or substance abuse or psychiatric illnesses.
* Participation in other study.
* The clinical context is suboptimal for renal denervation.

Answer: A