First report of the global SYMPLICITY registry on the effect of renal artery denervation in patients with uncontrolled hypertension

M. Böhm, F. Mahfoud, C. Ukena, U.C. Hoppe, K. Narkiewicz, M. Negoita, L. Ruilope, Markus Schlaich, R.E. Schmieder, R. Whitbourn, B. Williams, U. Zeymer, A. Zirlik, G. Mancia

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    Abstract

    © 2015 American Heart Association, Inc. This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. Clinical Trial Registration - URL: www.clinicaltrials.gov. Unique identifier: NCT01534299.
    Original languageEnglish
    Pages (from-to)766-774
    JournalHypertension
    Volume65
    Issue number4
    DOIs
    Publication statusPublished - 2015

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    Denervation
    Renal Artery
    Registries
    Blood Pressure
    Hypertension
    Kidney
    Safety
    Antihypertensive Agents
    Hospitalization
    Emergencies
    Clinical Trials

    Cite this

    Böhm, M. ; Mahfoud, F. ; Ukena, C. ; Hoppe, U.C. ; Narkiewicz, K. ; Negoita, M. ; Ruilope, L. ; Schlaich, Markus ; Schmieder, R.E. ; Whitbourn, R. ; Williams, B. ; Zeymer, U. ; Zirlik, A. ; Mancia, G. / First report of the global SYMPLICITY registry on the effect of renal artery denervation in patients with uncontrolled hypertension. In: Hypertension. 2015 ; Vol. 65, No. 4. pp. 766-774.
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    title = "First report of the global SYMPLICITY registry on the effect of renal artery denervation in patients with uncontrolled hypertension",
    abstract = "{\circledC} 2015 American Heart Association, Inc. This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P70{\%} and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. Clinical Trial Registration - URL: www.clinicaltrials.gov. Unique identifier: NCT01534299.",
    author = "M. B{\"o}hm and F. Mahfoud and C. Ukena and U.C. Hoppe and K. Narkiewicz and M. Negoita and L. Ruilope and Markus Schlaich and R.E. Schmieder and R. Whitbourn and B. Williams and U. Zeymer and A. Zirlik and G. Mancia",
    year = "2015",
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    Böhm, M, Mahfoud, F, Ukena, C, Hoppe, UC, Narkiewicz, K, Negoita, M, Ruilope, L, Schlaich, M, Schmieder, RE, Whitbourn, R, Williams, B, Zeymer, U, Zirlik, A & Mancia, G 2015, 'First report of the global SYMPLICITY registry on the effect of renal artery denervation in patients with uncontrolled hypertension' Hypertension, vol. 65, no. 4, pp. 766-774. https://doi.org/10.1161/HYPERTENSIONAHA.114.05010

    First report of the global SYMPLICITY registry on the effect of renal artery denervation in patients with uncontrolled hypertension. / Böhm, M.; Mahfoud, F.; Ukena, C.; Hoppe, U.C.; Narkiewicz, K.; Negoita, M.; Ruilope, L.; Schlaich, Markus; Schmieder, R.E.; Whitbourn, R.; Williams, B.; Zeymer, U.; Zirlik, A.; Mancia, G.

    In: Hypertension, Vol. 65, No. 4, 2015, p. 766-774.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - First report of the global SYMPLICITY registry on the effect of renal artery denervation in patients with uncontrolled hypertension

    AU - Böhm, M.

    AU - Mahfoud, F.

    AU - Ukena, C.

    AU - Hoppe, U.C.

    AU - Narkiewicz, K.

    AU - Negoita, M.

    AU - Ruilope, L.

    AU - Schlaich, Markus

    AU - Schmieder, R.E.

    AU - Whitbourn, R.

    AU - Williams, B.

    AU - Zeymer, U.

    AU - Zirlik, A.

    AU - Mancia, G.

    PY - 2015

    Y1 - 2015

    N2 - © 2015 American Heart Association, Inc. This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. Clinical Trial Registration - URL: www.clinicaltrials.gov. Unique identifier: NCT01534299.

    AB - © 2015 American Heart Association, Inc. This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. Clinical Trial Registration - URL: www.clinicaltrials.gov. Unique identifier: NCT01534299.

    U2 - 10.1161/HYPERTENSIONAHA.114.05010

    DO - 10.1161/HYPERTENSIONAHA.114.05010

    M3 - Article

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    SP - 766

    EP - 774

    JO - Hypertension

    JF - Hypertension

    SN - 0194-911X

    IS - 4

    ER -