Rationale and design of a large registry on renal denervation: The Global SYMPLICITY registry

Michael Böhm, Felix Mahfoud, Christian Ukena, Axel Bauer, Eckart Fleck, Uta C. Hoppe, Ulrich Kintscher, Krzysztof Narkiewicz, Manuela Negoita, Luis Ruilope, L. Christian Rump, Markus Schlaich, Roland Schmieder, Horst Sievert, Joachim Weil, Bryan Williams, Uwe Zeymer, Giuseppe Mancia

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

Aims: Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure. Methods and results: The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities. Conclusions: The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.

Original languageEnglish
Pages (from-to)484-492
Number of pages9
JournalEuroIntervention
Volume9
Issue number4
DOIs
Publication statusPublished - Aug 2013
Externally publishedYes

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Denervation
Registries
Hypertension
Kidney
Renal Artery
Blood Pressure
Comorbidity
Clinical Trials
Glucose Intolerance
Sleep Apnea Syndromes
Chronic Renal Insufficiency
Germany
Heart Failure
Delivery of Health Care
Safety
Brain

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Böhm, M., Mahfoud, F., Ukena, C., Bauer, A., Fleck, E., Hoppe, U. C., ... Mancia, G. (2013). Rationale and design of a large registry on renal denervation: The Global SYMPLICITY registry. EuroIntervention, 9(4), 484-492. https://doi.org/10.4244/EIJV9I4A78
Böhm, Michael ; Mahfoud, Felix ; Ukena, Christian ; Bauer, Axel ; Fleck, Eckart ; Hoppe, Uta C. ; Kintscher, Ulrich ; Narkiewicz, Krzysztof ; Negoita, Manuela ; Ruilope, Luis ; Rump, L. Christian ; Schlaich, Markus ; Schmieder, Roland ; Sievert, Horst ; Weil, Joachim ; Williams, Bryan ; Zeymer, Uwe ; Mancia, Giuseppe. / Rationale and design of a large registry on renal denervation : The Global SYMPLICITY registry. In: EuroIntervention. 2013 ; Vol. 9, No. 4. pp. 484-492.
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Böhm, M, Mahfoud, F, Ukena, C, Bauer, A, Fleck, E, Hoppe, UC, Kintscher, U, Narkiewicz, K, Negoita, M, Ruilope, L, Rump, LC, Schlaich, M, Schmieder, R, Sievert, H, Weil, J, Williams, B, Zeymer, U & Mancia, G 2013, 'Rationale and design of a large registry on renal denervation: The Global SYMPLICITY registry' EuroIntervention, vol. 9, no. 4, pp. 484-492. https://doi.org/10.4244/EIJV9I4A78

Rationale and design of a large registry on renal denervation : The Global SYMPLICITY registry. / Böhm, Michael; Mahfoud, Felix; Ukena, Christian; Bauer, Axel; Fleck, Eckart; Hoppe, Uta C.; Kintscher, Ulrich; Narkiewicz, Krzysztof; Negoita, Manuela; Ruilope, Luis; Rump, L. Christian; Schlaich, Markus; Schmieder, Roland; Sievert, Horst; Weil, Joachim; Williams, Bryan; Zeymer, Uwe; Mancia, Giuseppe.

In: EuroIntervention, Vol. 9, No. 4, 08.2013, p. 484-492.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rationale and design of a large registry on renal denervation

T2 - The Global SYMPLICITY registry

AU - Böhm, Michael

AU - Mahfoud, Felix

AU - Ukena, Christian

AU - Bauer, Axel

AU - Fleck, Eckart

AU - Hoppe, Uta C.

AU - Kintscher, Ulrich

AU - Narkiewicz, Krzysztof

AU - Negoita, Manuela

AU - Ruilope, Luis

AU - Rump, L. Christian

AU - Schlaich, Markus

AU - Schmieder, Roland

AU - Sievert, Horst

AU - Weil, Joachim

AU - Williams, Bryan

AU - Zeymer, Uwe

AU - Mancia, Giuseppe

PY - 2013/8

Y1 - 2013/8

N2 - Aims: Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure. Methods and results: The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities. Conclusions: The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.

AB - Aims: Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure. Methods and results: The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities. Conclusions: The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.

KW - Cardiovascular interventions

KW - Hypertension

KW - Renal denervation

KW - Resistant hypertension

KW - Sympathetic nervous system

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