SPYRAL DYSTAL
INCLUSION Criteria
- Individual is ≥20 and ≤80 years old at time of enrollment(consent).
- Individual has an office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg and an office diastolic blood pressure (DBP) ≥90mm Hg measured at Screening Visit 2, according to the guidelines in Appendix 16.5.
- Individual has a valid 24-hour Ambulatory Blood PressureMonitoring (ABPM) average SBP ≥140 mmHg and <170 mmHg measured at Screening Visit 2, according to guidelines in Appendix16.5.
- ABPM is considered valid if the number of successful daytime readings captured is ≥21 and the number of successful nighttime readings captured ≥12.
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
- Individual is willing to discontinue current antihypertensive medications at Screening Visit 1 through the 3-month postprocedure visit.
EXCLUSION Criteria
- Individual has one or more of the following conditions: 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. Patients are permitted to take aspirin or clopidogrel for cardiovascular risk reduction. Patients who received catheter or surgical treatment for Atrial Fibrillation and are in sinus rhythm are not excluded.
- Individual has undergone prior renal denervation.
- Individual has at least one main renal artery with a diameter of less than 3 mm or greater than 8 mm.
- Presence of FMD (defined as visible beading of the artery on angiography).
- Has >50% stenosis in any treatable vessel.
- Has a renal artery stent placed <3 months prior to the denervation procedure.
- Presence of a renal artery aneurysm defined as any localized increase in the diameter of the vessel.
- Disease not allowing any treatment in the main renal artery.
- Individual has an estimated glomerular filtration rate (eGFR) of <45 ml/min/1.73m2 , using the 4 variable MORD calculation (in ml/min per 1.73 m2 = 175 x Serum cr-1.154 x age-0 · 203 x 1.212 (if patient is black) x 0.742 (if female)).
- Individual has documented type 1 diabetes mellitus or poorlycontrolled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%. (If the glycosylated hemoglobin in the patient's records is >3 months old (from the date of Screening Visit 2), or history of uncontrolled blood sugars raises concern, it is required to analyze glycosylated hemoglobin as part of Screening Visit 2 labs.)
- Individual is taking SGLT2 inhibitor or GLP-1 agonists that have been prescribed <90 days prior to Screening Visit 1 or who does not plan on remaining on these drugs for the duration of the trial.
- Individual has had ≥1 episode(s) of orthostatic hypotension not related to medication changes within the past year or has a reduction of SBP ≥20 mm Hg or DBP ≥10 mmHg within 3 minutes of standing coupled with symptoms during the screening process (at SV2).
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g. CPAP, BiPAP).
- Individual with a history of narcotic drug abuse, is currently on Methadone, or who has used narcotic drugs more than once in the month prior to Screening Visit 1.
- Individual had documented primary pulmonary hypertension.
- Individual has untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone that could contribute to hypertension.
- Individual has frequent intermittent or chronic pain that results in treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to Screening Visit 2.
- Individual with HIV on anti-retroviral drug therapy without documentation that hypertension preceded initiation of antiretroviral drug treatment.
- Individual has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints.
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic/office blood pressure monitor (e.g., upper arm circumference outside cuff size ranges available by geography or arrhythmia such as atrial fibrillation that interferes with automatic monitor's pulse sensing and prohibits an accurate measurement).
- Individual works night shifts.
- Individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a significant reduction of blood pressure is contraindicated.
- Individual has a documented confounding medical condition, which in the opinion of the investigator, may adversely affect the safety of the participant (e.g. patients with clinically significant peripheral vascular disease, aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia).
- Individual is pregnant, nursing or planning to become pregnant during the course of the study follow-up. (Note: Pre-menopausal female participants must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
- Individual has a known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the investigator, to comply with study follow-up requirements.
- Individual is currently enrolled in a concurrent investigational drug or device study, unless approved by the study sponsor. (Note: For the purpose of this protocol, participants involved in extended follow-up studies for products that were investigational but are currently commercially available are not considered enrolled in an investigational study).
- Individual is currently taking anti-mineralocorticoid drugs. (Note: Subjects may be enrolled as long as anti-mineralocorticoid drugs are weaned off at least 8 weeks prior to Screening Visit 1).
- Individual has an active peptic ulcer or gastrointestinal (GI) bleeding within the prior six months from consent.
- Individual has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Individual has polycystic kidney disease, unilateral kidney,atrophic kidney, or history of renal transplant.
Ansprechpartner
Priv.-Doz. Dr. med. MHBA
Ewen,
Sebastian
Ärztlicher Leiter der Zentralen Notaufnahme (ZNA), Leiter Echokardiographie
Prof. Dr. med. M. A.
Mahfoud,
Felix
Leitender Oberarzt
Ansprechpartner im Studienzentrum
Neurath,
Barbara
Leitung Studienambulanz (Geb. 24)
Dr.
Wachter,
Angelika
Stellv. Leitung Studienzentrum (Geb. 24)
