Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.
J Hypertens
; 34(8): 1639-47, 2016 08.
Article
en En
| MEDLINE
| ID: mdl-27228432
ABSTRACT
BACKGROUND:
Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP.METHOD:
We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145âmmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA).RESULTS:
We randomized 69 patients with treatment-resistant hypertension to RDN (nâ=â36) or SHAM (nâ=â33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159â±â12âmmHg (RDN) and 159â±â14âmmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2â±â18.8âmmHg (RDN) vs. -6.0â±â13.5âmmHg (SHAM)] and at 6 months [-6.1â±â18.9âmmHg (RDN) vs. -4.3â±â15.1âmmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8â±â2.7 (RDN) vs. 7.0â±â2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial.CONCLUSION:
Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Simpatectomía
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Presión Sanguínea
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Vasoespasmo Coronario
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Hipertensión
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Riñón
Tipo de estudio:
Clinical_trials
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Hypertens
Año:
2016
Tipo del documento:
Article