Randomized Sham-Controlled Trial of Renal Sympathetic Denervation in Mild Resistant Hypertension
| Autor: | Ulrike Müller, Melanie Sonnabend, Steffen Desch, Konrad Kulle, Thomas Okon, Diana Heinemann, Philipp Lurz, Karoline Röhnert, Martin Petzold, Holger Thiele, Gerhard Schuler, Ingo Eitel |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Population Drug Resistance Kidney Risk Assessment Severity of Illness Index law.invention Randomized controlled trial Reference Values law Internal medicine Confidence Intervals Internal Medicine medicine Humans Single-Blind Method Sympathectomy education Antihypertensive Agents Aged Denervation education.field_of_study Intention-to-treat analysis business.industry Blood Pressure Determination Middle Aged Confidence interval Surgery Treatment Outcome Blood pressure Renal sympathetic denervation Hypertension Ambulatory Cardiology Female business Follow-Up Studies |
| Zdroj: | Hypertension. 65:1202-1208 |
| ISSN: | 1524-4563 0194-911X |
| Popis: | Few data are available with regard to the effectiveness of renal sympathetic denervation in patients with resistant hypertension yet only mildly elevated blood pressure (BP). Patients with resistant hypertension and slightly elevated BP (day-time systolic pressure, 135–149 and diastolic pressure, 90–94 mm Hg on 24-hour ambulatory measurement) were randomized in a 1:1 ratio to renal sympathetic denervation with the Symplicity Flex Catheter (Medtronic) or an invasive sham procedure. The primary efficacy end point was the change in 24-hour systolic BP at 6 months between groups in the intention to treat population. A total of 71 patients underwent randomization. Baseline day-time systolic BP was 144.4±4.8 mm Hg in patients assigned to denervation and 143.0±4.7 mm Hg in patients randomized to the sham procedure. The mean change in 24-hour systolic BP in the intention to treat cohort at 6 months was −7.0 mm Hg (95% confidence interval, −10.8 to −3.2) for patients undergoing denervation and −3.5 mm Hg (95% confidence interval, −6.7 to −0.2) in the sham group ( P =0.15). In the per protocol population, the change in 24-hour systolic BP at 6 months was −8.3 mm Hg (95% confidence interval, −11.7 to −5.0) for patients undergoing denervation and −3.5 mm Hg (95% confidence interval, −6.8 to −0.2) in the sham group ( P =0.042). In patients with mild resistant hypertension, renal sympathetic denervation failed to show a significant reduction in the primary end point of 24-hour systolic BP at 6 months between groups in the intention to treat analysis. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01656096. |
| Databáze: | OpenAIRE |
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