SPYRAL HTN-ON MED Study

  • STATUS
    Recruiting
  • End date
    Jul 15, 2025
  • participants needed
    340
  • sponsor
    Medtronic Vascular
Updated on 15 October 2020
Investigator
K Wandrey
Primary Contact
Universit tsklinikum Erlangen (8.7 mi away) Contact
+75 other location
systolic blood pressure
antihypertensive drugs
ambulatory blood pressure monitoring
24-hour ambulatory blood pressure monitoring

Summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Details
Treatment Symplicity Spyral™ multi-electrode renal denervation system, Sham Procedure
Clinical Study IdentifierNCT02439775
SponsorMedtronic Vascular
Last Modified on15 October 2020

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Eligibility

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Inclusion Criteria

Is your age between 20 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes and Hypertension or Hypertension or Vascular Diseases or High Blood Pressure (Hypertension) or Cardiovascular Disease or High Blood Pressure ...?
Individual has office systolic blood pressure (SBP) 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes
Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP 140 mmHg and < 170 mmHg

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
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Step 4 Get your study results

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