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Медицинская библиотека · The Netherlands journal of medicine · 2016

Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry.

Sanders M F, Blankestijn P J, Voskuil M, Spiering W, Vonken E J, Rotmans J I, van der Hoeven B L, Daemen J, van den Meiracker A H, Kroon A A, de Haan M W, Das M, Bax M, van der Meer I M, van Overhagen H, van den Born B J H, van Brussel P M, van der Valk P H M, Smak Gregoor P J H, Meuwissen M, Gomes M E R, Oude Ophuis T, Troe E, Tonino W A L, Konings C J A M, de Vries P A M, van Balen A, Heeg J E, Smit J J J, Elvan A, Steggerda R, Niamut S M L, Peels J O J, de Swart J B R M, Wardeh A J, Groeneveld J H M, van der Linden E, Hemmelder M H, Folkeringa R, Stoel M G, Kant G D, Herrman J P R, van Wissen S, Deinum J, Westra S W, Aengevaeren W R M, Parlevliet K J, Schramm A, Jessurun G A J, Rensing B J W M, Winkens M H M, Wierema T K A, Santegoets E, Lipsic E, Houwerzijl E, Kater M, Allaart C P, Nap A, Bots M L

СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

BACKGROUND

Percutaneous renal denervation (RDN) has recently been introduced as a treatment for therapy-resistant hypertension. Also, it has been suggested that RDN may be beneficial for other conditions characterised by increased sympathetic nerve activity. There are still many uncertainties with regard to efficacy, safety, predictors for success and long-term effects. To answer these important questions, we initiated a Dutch RDN registry aiming to collect data from all RDN procedures performed in the Netherlands.

METHODS

The Dutch RDN registry is an ongoing investigator-initiated, prospective, multicentre cohort study. Twenty-six Dutch hospitals agreed to participate in this registry. All patients who undergo RDN, regardless of the clinical indication or device that is used, will be included. Data are currently being collected on eligibility and screening, treatment and follow-up.

RESULTS

Procedures have been performed since August 2010. At present, data from 306 patients have been entered into the database. The main indication for RDN was hypertension (n = 302, 99%). Patients had a mean office blood pressure of 177/100 (±29/16) mmHg with a median use of three (range 0-8) blood pressure lowering drugs. Mean 24-hour blood pressure before RDN was 157/93 (±18/13) mmHg. RDN was performed with different devices, with the Simplicity™ catheter currently used most frequently.

CONCLUSION

Here we report on the rationale and design of the Dutch RDN registry. Enrolment in this investigator-initiated study is ongoing. We present baseline characteristics of the first 306 participants.

Для цитирования: Sanders M F, Blankestijn P J, Voskuil M, Spiering W, Vonken E J, Rotmans J I, van der Hoeven B L, Daemen J, van den Meiracker A H, Kroon A A, de Haan M W, Das M, Bax M, van der Meer I M, van Overhagen H, van den Born B J H, van Brussel P M, van der Valk P H M, Smak Gregoor P J H, Meuwissen M, Gomes M E R, Oude Ophuis T, Troe E, Tonino W A L, Konings C J A M, de Vries P A M, van Balen A, Heeg J E, Smit J J J, Elvan A, Steggerda R, Niamut S M L, Peels J O J, de Swart J B R M, Wardeh A J, Groeneveld J H M, van der Linden E, Hemmelder M H, Folkeringa R, Stoel M G, Kant G D, Herrman J P R, van Wissen S, Deinum J, Westra S W, Aengevaeren W R M, Parlevliet K J, Schramm A, Jessurun G A J, Rensing B J W M, Winkens M H M, Wierema T K A, Santegoets E, Lipsic E, Houwerzijl E, Kater M, Allaart C P, Nap A, Bots M L. Safety and long-term effects of renal denervation: Rationale and design of the Dutch registry.. The Netherlands journal of medicine. 2016.

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